Comparing the Efficacy and Safety of Adapalene Gel and Hyaluronic Acid Versus Adapalene Gel Alone in Mild to Moderate Acne Vulgaris: An Open-label Randomized Controlled Trial.

Acne vulgaris affects around 85% of adolescents and young adults. Adapalene, a topical retinoid, is a common treatment but often causes irritation, leading to poor adherence. Hyaluronic acid (HA), known for its hydrating and anti-inflammatory properties, may help reduce these side effects.
This prospective, open-label, randomized controlled trial compares adapalene 0.1% gel combined with HA serum versus adapalene alone over 8 weeks in patients with mild to moderate acne. Key outcomes include acne lesion reduction, incidence and severity of side effects (erythema, dryness, scaling, stinging/burning, pruritus), and skin hydration assessed through the skin turgor test. Acne severity will be measured using the Acne Severity Index (ASI) and Investigator's Global Assessment (IGA) scale.
The study anticipates better efficacy, reduced irritation, and improved skin hydration with the combination therapy. Ethical approval was obtained, and informed consent will be secured from all participants.

Start Date21 Jul 2025

Sponsor / Collaborator

Badr University In Cairo

NCT07016360

/ RecruitingPhase 4IIT

Comparison of Efficacy of Topical Adapalene Gel Versus Cryotherapy in Recurrent Plantar Warts

This is a comparative study between two treatment options for skin viral infection.

Start Date15 Jun 2025

Sponsor / Collaborator

Khyber Teaching Hospital

CTRI/2025/03/082481

/ Not yet recruitingPhase 2/3IIT

A RANDOMIZED, PARALLEL GROUP, OPEN LABEL, ACTIVE CONTROLLED CLINICAL STUDY TO COMPARE THE SAFETY AND EFFICACY OF A TOPICAL UNANI FORMULATION WITH ADAPALENE (0.1 percent) IN THE MANAGEMENT OF BUTHUR LABANIYYA (ACNE VULGARIS) - NIL

Start Date01 Jun 2025

Sponsor / Collaborator-

100 Clinical Results associated with Adapalene

100 Translational Medicine associated with Adapalene

100 Patents (Medical) associated with Adapalene

887

Literatures (Medical) associated with Adapalene

31 Dec 2026·JOURNAL OF DERMATOLOGICAL TREATMENT

Long-term efficacy and tolerability of clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel for acne: pooled results from two 6-month studies

Article

Author: Tanghetti, Emil A. ; Wroblewski, Karol ; Ghannoum, Mahmoud ; Harper, Julie C. ; Kircik, Leon H. ; Baldwin, Hilary ; Draelos, Zoe D. ; Gold, Linda Stein

AIM:

Given the chronic nature of acne, two 6-month studies were conducted to evaluate the long-term efficacy and tolerability of clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1% gel (CAB)-the only approved triple-combination acne topical-and its effects on scarring/dyspigmentation in participants with moderate to severe acne.

MATERIALS AND METHODS:

Data were pooled from 2 identical, open-label, single-center studies conducted in participants (N = 50) aged ≥12 years with Investigator's Global Assessment (IGA) score of 3/4. Endpoints included change from baseline in IGA score, inflammatory/noninflammatory lesions, skin appearance (dryness, postinflammatory hyperpigmentation [PIH], postinflammatory erythema [PIE]), and scarring. Adverse events and tolerability (itching, burning, redness, swelling) were assessed.

RESULTS:

At week 24, 67% of participants achieved treatment success, and significant reductions from baseline in inflammatory (88%) and noninflammatory (68%) lesions were observed (p < 0.001, both). Significant reductions in scarring (33%), investigator- and participant-assessed PIH (71%; 78%, respectively), and PIE (77%; 77%, respectively) were demonstrated (p < 0.001, all). Most participants (>70%) reported no tolerability issues throughout the studies. Seven adverse events occurred; 4 were related to CAB, and 3 led to study discontinuation (BPO allergy [n = 2], irritant contact dermatitis to BPO [n = 1]).

CONCLUSIONS:

These findings suggest that CAB is an appropriate and effective topical option for the long-term treatment of acne vulgaris.

01 Feb 2026·Drug Delivery and Translational Research

Dual drug co-encapsulation into liposomes and liposome-derived nanosystems for improved synergistic treatment of skin diseases

Review

Author: Pires, Patrícia C ; Rodrigues, Sara ; Veiga, Francisco ; Paiva-Santos, Ana Cláudia

Skin disorders impact nearly one-third of the global population, and represent the fourth most common cause of human diseases. However, delivering drugs into and through the skin is a significant challenge due to its low permeability, which severely limits the efficacy of conventional topical and transdermal formulations. To tackle this issue, liposomes and liposome-derived nanosystems can be of use, which, among other advantages, also have the capacity to encapsulate more than one drug molecule simultaneously, allowing combination therapy. This review provides a comprehensive summary and critical analysis of recent studies regarding dual drug co-encapsulation into liposomes and liposome-derived nanosystems as an improved therapeutic approach for the treatment of several skin diseases, such as acne vulgaris, androgenetic alopecia, cutaneous leishmaniasis, psoriasis, vitiligo, and chronic wounds, and for dermal analgesia and general skin oxidative stress management purposes. Conventional and modified liposomes, niosomes, transfersomes, ethosomes, invasomes, cerosomes, liposomal gels, and niosomal gels were developed, co-encapsulating synthetic and nature-derived substances such as adapalene, amphotericin B, benzoyl peroxide, bicalutamide, bupivacaine, buprenorphine, curcumin, ginger, glycyrrhetinic acid, metformin, methotrexate, microRNA-21, minoxidil, nicotinamide, Nigella sativa seed oil, pentamidine, psoralen, resveratrol, simvastatin, tocopherol acetate, tretinoin, and virgin coconut oil. By co-encapsulating active substances with distinct mechanisms of action, the developed nanosystems provide synergistic therapeutic effects, leading to reduced toxicity and enhanced bioavailability, potentially resulting in improved clinical outcomes, and presenting a promising alternative to conventional treatments. Through addressing clinical and regulatory framework aspects, these innovative therapies might one day transition from bench to market to improve the patient's quality-of-life.

01 Jan 2026·THERIOGENOLOGY

13-cis-retinoic acid modulates porcine ovarian granulosa cell differentiation via retinoic acid signaling-FoxA1 axis: Implications for ovarian follicular development and luteinization

Article

Author: Ma, Li ; Mi, Yi-Xuan ; Wang, Shui-Lian ; Zhang, Hong-Liang ; Zhao, Ming ; Bao, Li ; Wu, Xia-Meng ; Wang, Hua-Biao

13-cis-Retinoic acid (13cRA), a vitamin A derivative clinically employed in cancer therapy, demonstrates novel regulatory effects on ovarian follicular development and luteinization through granulosa cell proliferation and differentiation in this study. Our murine model revealed that 13cRA administration significantly increased the number of primary follicle and corpus luteum by ovarian sectioning and follicle counting, indicating accelerated follicular maturation and ovulation competence. In porcine ovarian granulosa cell cultures, 13cRA treatment induced cell cycle progression (G1-S phase transition), and promoted cell proliferation while up-regulating differentiation markers luteinizing hormone receptor (LHR) and progesterone receptor (PGR). Cellular retinoic acid-binding protein CRABP2-mediated mechanisms were identified as pivotal through gain/loss-of-function experiments. Overexpression of CRABP2 amplified 13cRA-induced LHR and PGR expression, while knockdown of CRABP2 by specific siRNA resulted in the opposite effect. The retinoid acid signaling axis was further delineated through receptor-specific modulation. 13cRA promoted RARβ/RXRβ receptor heterodimer formation, with pharmacological activation (Adapalene) potentiating LHR and PGR expression and receptor knockdown diminishing their expression. RA metabolic regulation studies revealed that CRABP1 and CYP26 isoforms (CYP26A1 and CYP26B1) as functional antagonists of 13cRA activity were demonstrated through siRNA silencing or CYP26 inhibitor R115866 treatment experiments. Notably, we identified that FoxA1, as a negative regulator of granulosa cell proliferation and differentiation, mediated the effect of 13cRA on granulosa cell differentiation through siRNA transfection and FoxA1 recombinant protein treatment experiments. 13cRA-mediated FoxA1 expression suppression occurred through CRABP2-dependent nuclear shuttling and RARβ/RXRβ receptor heterodimer activating, with combinatorial modulation of CRABP1/CYP26 system components (CYP26A1 and CYP26B1) significantly altering FoxA1 regulatory dynamics. Finally, we conclude that 13cRA can inhibit FoxA1 expression through RA signaling molecules (CRABP2, RARβ/RXRβ heterodimer, CRABP1, CYP26A1 and CYP26B1) and thus promote the differentiation of porcine ovarian granulosa cells.

News (Medical) associated with Adapalene

02 Nov 2025

·pharma.economictimes.indiatimes.com

Drugmakers must face skincare drug price-fixing lawsuit, US judge rules

New York: A federal judge on Friday said 36 drugmakers and executives must face nearly all claims in an antitrust lawsuit brought by most U.S. states, accusing them of conspiring to fix prices of 80 generic drugs. Chief Judge Michael Shea of the federal district court in Connecticut rejected claims that 45 states, the District of Columbia and four U.S. territories waited an unreasonably long time to pursue federal antitrust claims, and missed formal deadlines to file similar claims under state laws. Led by Connecticut, the states accused drugmakers including Pfizer , Perrigo and Sandoz of conspiring to raise prices, limit competition and allocate customers for drugs, primarily for skin ailments, between 2009 and 2016. In a 130-page decision, Shea said the defendants failed to show that the states "lacked diligence" in pursuing their case, citing evidence that the defendants pursued "affirmative acts" to conceal their alleged collusion. "A reasonable juror could find that the defendants' 'blaming supply,' making uncompetitively high bids, and falsely citing production costs for increased prices were aimed at concealing their alleged conspiracy," the Hartford-based judge wrote. Lawyers for Pfizer, Perrigo and Sandoz did not immediately respond to requests for comment after market hours. A spokeswoman for Connecticut Attorney General William Tong did not immediately respond to a similar request. Brand names of some products in the case included the acne medication Differin, anti-fungal medicine Lotrimin AF Cream, and Ritalin for attention deficit disorder and attention deficit hyperactivity disorder. The case is Connecticut et al v. Sandoz Inc et al, U.S. District Court, District of Connecticut, No. 20-00802. (Reporting by Jonathan Stempel in New York; Editing by Himani Sarkar)

Patent Infringement

21 Aug 2025

·ir.bauschhealth.com

Le traitement pour l’acné vulgaire de Bausch Health, Canada Inc., PrCABTREOMC (gel de phosphate de clindamycine, d’adapalène et de peroxyde de benzoyle), est maintenant couvert par les régimes publics du Québec et de la Saskatchewan LAVAL, QC, le 21 août 2025 – Bausch Health, Canada Inc., une filiale de Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), a annoncé aujourd'hui que PrCABTREOMC en gel 1,2 %/0,15 %/3,1 % (phosphate de clindamycine, adapalène et peroxyde de benzoyle), pour le traitement de l'acné vulgaire1, est désormais couvert pour les bénéficiaires des régimes publics d’assurance médicaments du Québec et de la Saskatchewan. Cette nouvelle inscription de CABTREO aux régimes publics d'assurance-médicaments s'ajoute à celle annoncée le mois dernier pour les personnes inscrites aux régimes publics d'assurance-médicaments de l'Ontario et de la Nouvelle-Écosse, ainsi que du programme fédéral des services non assurés (PMNA) destiné aux populations autochtones, de celui du Service correctionnel du Canada (SCC), et de celui d'Anciens Combattants Canada. CABTREO est un nouveau traitement topique sur ordonnance combinant trois ingrédients, fabriqué au Canada, indiqué pour l’acné vulgaire chez les patients âgés de 12 ans et plus. Il s’agit du premier et unique traitement topique à triple combinaison approuvé par Santé Canada pour l’acné, réunissant trois mécanismes d’action — un antibiotique, un rétinoïde et un agent antibactérien — afin d’offrir une option thérapeutique sûre et efficace1. « L’ajout de CABTREO aux régimes publics d’assurance-médicaments du Québec et de la Saskatchewan signifie que davantage de Canadiens ont maintenant accès à ce traitement novateur contre l’acné, en plus de ceux déjà couverts par la plupart des régimes privés », a déclaré Amy Cairns, directrice générale de Bausch Health, Canada. « L’acné peut affecter grandement la vie de ceux qui en souffrent, et la forte demande pour de nouvelles options de traitement rend la couverture publique d’autant plus essentielle. » CABTREO est un gel topique sur ordonnance à appliquer une fois par jour sur les zones affectées de la peau. Ses ingrédients actifs sont l'antibiotique phosphate de clindamycine, le rétinoïde topique adapalène et l'agent oxydant peroxyde de benzoyle qui a une activité bactéricide à large spectre1. À propos de l’acné vulgaire L’acné vulgaire (« vulgaire » signifie « commune ») est le problème cutané le plus fréquemment observé par les médecins au Canada. Elle se développe lorsque les pores se bouchent de sébum et de cellules cutanées, entraînant souvent des points blancs, des points noirs, des boutons ou des kystes sur le visage, le front, la poitrine, le haut du dos et les épaules. L’acné touche environ 5,6 millions de Canadiens, ou près de 20 % de la population, dont environ 90 % des adolescents. On estime que pour environ 25 % des adolescents, l’acné peut persister jusqu’à l’âge de 25 ans. L’acné peut causer une détresse émotionnelle ainsi que des cicatrices permanentes² et entraîner des troubles de pigmentation cutanée3. Données cliniques et informations de sécurité de CABTREO CABTREO a fait l'objet de deux études cliniques multicentriques de phase 3, aléatoires et contrôlées par placebo, menées auprès de 363 patients présentant de l'acné vulgaire faciale. Les deux études ont atteint tous les critères d'efficacité primaires, notamment le changement absolu du nombre de lésions inflammatoires et non inflammatoires par rapport à l’inclusion, ainsi que le pourcentage de patients ayant atteint le succès du traitement prédéfini. Les résultats d'efficacité combinés des deux études pour CABTREO ont démontré un taux de réussite du traitement d'environ 50 % et une réduction de plus de 70 % des lésions inflammatoires et non inflammatoires à la semaine 121. Les réactions indésirables les plus fréquentes pouvant survenir avec CABTREO sont des réactions légères ou modérées au niveau du site d'application. Par exemple, une irritation cutanée caractérisée par une desquamation, une sécheresse, un érythème (rougeur) et une sensation de brûlure ou de picotement. CABTREO ne doit pas être utilisé par les personnes hypersensibles à l'un des ingrédients qu'il contient (phosphate de clindamycine, adapalène, peroxyde de benzoyle ou à tout autre ingrédient dans la préparation), par les patients ayant des antécédents d'entérite régionale (maladie de Crohn), de colite ulcéreuse ou de colite associée aux antibiotiques, ni par les femmes enceintes ou celles qui planifient une grossesse. CABTREO peut décolorer les cheveux et les tissus colorés. Il convient donc de faire preuve de prudence lors de l'application du produit près de la racine des cheveux1. Santé Canada n'a pas autorisé l'utilisation de CABTREO chez les enfants de moins de 12 ans. CABTREO est destiné à un usage topique uniquement et n'est pas destiné à un usage oral, ophtalmique ou intravaginal1. À propos de la dermatologie chez Bausch Health, Canada Inc. Bausch Health, Canada Inc. possède l'un des plus grands portefeuilles de dermatologie sur ordonnance au Canada, dédié à aider les patients dans le traitement de diverses affections thérapeutiques, notamment le psoriasis, la kératose actinique, l'acné, la dermatite atopique et d'autres dermatoses. Le portefeuille dermatologique de Bausch Health, Canada comprend plusieurs produits de pointe contre l'acné, le psoriasis, les mycoses et les dermatoses sensibles aux corticostéroïdes. CABTREO devient ainsi le quatrième traitement dermatologique de Bausch Health, Canada approuvé par Santé Canada et mis à la disposition des Canadiens au cours des quatre dernières années, enrichissant ainsi la gamme de produits de pointe de l’entreprise dans ce domaine thérapeutique important. Les autres produits approuvés sont la lotion ARAZLOMC (tazarotène), 0,045 % p/p, pour le traitement topique de l'acné vulgaire chez les patients âgés de 10 ans et plus ; BRYHALIMC (lotion au propionate d'halobétasol 0,01 % p/p), pour les dermatoses répondant aux corticostéroïdes et le traitement topique du psoriasis en plaques chez les adultes ; et DUOBRIIMC (propionate d'halobétasol 0,01% p/p et tazarotène 0,045 % p/p) pour traiter les adultes atteints de psoriasis en plaque de degré modéré ou sévère4. À propos de Bausch Health Bausch Health Companies Inc. (NYSE et TSX : BHC) est une société pharmaceutique mondiale à exploitation diversifiée ayant pour mission d’améliorer la vie des gens grâce à ses produits de santé. Elle met au point, fabrique et commercialise une gamme de produits, principalement dans les domaines de la gastroentérologie, de l’hépatologie, de la neurologie, de la dermatologie, les dispositifs médicaux esthétiques, la dentisterie, l'esthétique, les produits pharmaceutiques internationaux, ainsi que la santé oculaire, à travers sa participation majoritaire dans Bausch + Lomb. Nous aspirons à devenir une entreprise de soins de santé intégrée à l'échelle mondiale, reconnue et appréciée par les patients, les professionnels de la santé, les employés et les investisseurs. Pour plus de renseignements, visitez le site www.bauschhealth.com et communiquez avec nous sur LinkedIn. La gamme de médicaments d’ordonnance de Bausch Health, Canada Inc. cible principalement la dermatologie, les troubles gastro-intestinaux et les affections cardiométaboliques. Bausch Health possède deux usines de fabrication pour les médicaments d’ordonnance au Canada, une à Laval, au Québec, et l’autre à Steinbach, au Manitoba. Vous trouverez de plus amples renseignements sur le site Web de la société au www.bauschhealth.ca. Déclarations prospectives Ce communiqué de presse peut contenir des déclarations prospectives au sens des lois sur les valeurs mobilières applicables, y compris les dispositions de protection prévues par le U.S. Private Securities Litigation Reform Act de 1995. Les déclarations prospectives peuvent généralement être identifiées par l'utilisation de termes tels que « prévoit », « anticipe », « espère », « s'attend à », « à l'intention de », « planifie », « devrait », « pourrait », « voudrait », « peut », « croit », « sous réserve de », ainsi que par des expressions similaires ou des variations. Ces déclarations ne constituent ni des faits historiques ni des garanties de performance future. Elles sont fondées sur les attentes et les croyances actuelles de la direction et sont sujettes à certains risques et incertitudes qui pourraient entraîner des écarts significatifs entre les résultats réels et ceux décrits dans ces déclarations. Les résultats réels sont soumis à d'autres risques et incertitudes qui se rapportent plus généralement aux activités de Bausch Health, y compris ceux décrits de façon plus détaillée dans les rapports annuels et trimestriels les plus récents de Bausch Health, ainsi que dans les autres documents déposés de temps à autre auprès des Autorités canadiennes en valeurs mobilières et de la U.S. Securities and Exchange Commission, lesquels facteurs sont incorporés aux présentes par référence. Les lecteurs sont priés de ne pas accorder une trop grande confiance à ces déclarations prospectives. Ces déclarations prospectives ne sont valables qu'à la date du présent communiqué. La société ne s'engage aucunement à mettre à jour ces déclarations prospectives pour tenir compte d'événements, d'informations ou de circonstances survenus après la date de ce communiqué ou pour refléter des résultats réels, sauf si la loi l'exige. RÉFÉRENCES 1 Bausch Health, Canada Inc., monographie de produit CABTREO,https://pdf.hres.ca/dpd_pm/00076715.PDF. 2 Association canadienne de dermatologie, Acné, Faits saillants,https://dermatologue.ca/patients-et-grand-public/peau/acne/, consulté le 20 août 2024. 3 « What to Know about Hyperpigmentation Acne. » Medical News Today, Jessica Caporuscio, 28 avril 2021, https://www.medicalnewstoday.com/articles/hyperpigmentation-acne (en anglais), consulté le 20 août 2024. 4 Bausch Health, Canada Inc., Liste de produits canadiens, https://bauschhealth.ca/fr/produits/liste-de-produits-canadiens/.

Phase 3

21 Aug 2025

·ir.bauschhealth.com

Bausch Health, Canada Inc. treatment for acne vulgaris, PrCABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide gel), now available through public drug plans of Quebec and Saskatchewan

Bausch Health, Canada Inc. treatment for acne vulgaris, PrCABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide gel), now available through public drug plans of Quebec and Saskatchewan (English) LAVAL, QC, August 21, 2025 – Bausch Health, Canada Inc., part of Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), a global, diversified pharmaceutical company, today announced that PrCABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide) gel 1.2% w/w, 0.15% w/w and 3.1% w/w, for the treatment of acne vulgaris,1 is now available to beneficiaries of the public drug plans of Quebec and Saskatchewan. This new public drug plan availability of CABTREO is in addition to that announced last month for those using the Ontario and Nova Scotia public drug plans as well as through the federal government’s Non-Insured Health Benefits (NIHB) drug plan for Indigenous populations as well as those of the Correctional Service of Canada (CSC) and Veterans Affairs Canada. CABTREO is a new Canadian-made triple-combination topical prescription treatment for acne vulgaris in patients 12 years of age and older. CABTREO is the first and only triple-combination topical treatment for acne approved by Health Canada with three mechanisms of action – an antibiotic, a retinoid and an antibacterial agent – to provide a safe and effective treatment.1 “The addition of CABTREO to the Quebec and Saskatchewan public drug plans means more Canadians now have access to this innovative acne treatment – joining those already covered under most private insurance plans,” said Amy Cairns, General Manager, Bausch Health Canada. “Acne can have a significant impact on those living with it, and there is strong demand for new treatment options, increasing the importance of public drug plan coverage.” CABTREO, a prescription product, is a topical gel that is administered once daily to affected areas of the skin. Its active ingredients are the antibiotic clindamycin phosphate, the topical retinoid adapalene and the oxidizing agent benzoyl peroxide with a broad-spectrum bactericidal activity.1 About Acne Vulgaris Acne vulgaris ("vulgaris" means "common") is the most common skin problem seen by doctors in Canada. It occurs when the pores of the skin become plugged with oil and skin cells, often causing whiteheads, blackheads, pimples or cysts to appear on the face, forehead, chest, upper back and shoulders. Acne affects about 5.6 million Canadians, or nearly 20 per cent of the population, including about 90 per cent of adolescents. About 25 per cent of teens will still have acne at age 25. Acne causes emotional distress and can cause permanent scarring.2 It can also cause skin pigmentation changes.3 CABTREO Clinical Data and Safety Information CABTREO was studied in two phase 3 multicentre, randomized, placebo controlled clinical trials in 363 patients with facial acne vulgaris. Both studies met all co-primary efficacy endpoints, including absolute change from baseline in inflammatory lesion count, absolute change from baseline in non-inflammatory lesion count, and percentage of patients achieving pre-defined treatment success. Combined efficacy results for both trials for CABTREO achieved approximately 50% treatment success and a greater than 70% reduction in both inflammatory and noninflammatory lesions at Week 12.1 The most frequent adverse reactions that may occur with CABTREO are mild to moderate application site reactions, such as skin irritation characterized by scaling, dryness, erythema, and burning/stinging. CABTREO should not be used by those who are hypersensitive to any of the ingredients in it (clindamycin phosphate, adapalene, benzoyl peroxide or to any ingredient in the formulation), patients with a history of regional enteritis (Crohn’s disease), ulcerative colitis or antibiotic-associated colitis or by pregnant women and women planning a pregnancy. CABTREO may bleach hair and coloured fabric so caution should be used when applying it near the hairline.1 Health Canada has not authorized CABTREO for pediatric use under the age of 12 years. CABTREO is for topical use only and is not for oral, ophthalmic or intravaginal use.1 About Dermatology at Bausch Health, Canada Inc. Bausch Health, Canada Inc. has one of the largest prescription dermatology businesses in Canada dedicated to helping patients in the treatment of a range of therapeutic areas, including psoriasis, actinic keratosis, acne, atopic dermatitis and other dermatoses. The Bausch Health, Canada Inc. dermatology portfolio includes several leading acne, psoriasis, anti-fungal and corticosteroid-responsive dermatoses products. CABTREO is the fourth new dermatology treatment from Bausch Health, Canada Inc. approved by Health Canada and made available to Canadians over the past four years, adding to the company's leading portfolio in this important treatment area. The other approvals were for ARAZLOTM (tazarotene lotion, 0.045% w/w), for the topical treatment of acne vulgaris in patients 10 years of age and older; BRYHALI™ (halobetasol propionate lotion 0.01% w/w), for corticosteroid-responsive dermatoses and the topical treatment of plaque psoriasis in adults; and DUOBRII™ (0.01% w/w halobetasol propionate and 0.045% w/w tazarotene) to treat adults with moderate to severe plaque psoriasis.4 All four treatments – CABTREO, ARAZLO, BRYHALI and DUOBRII – are manufactured at Bausch Health's Laval, Quebec, facility for Canada and the United States. About Bausch Health Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn. The Bausch Health Canadian prescription treatment portfolio is focused on dermatology, gastrointestinal and cardio-metabolic conditions. Bausch Health also has two manufacturing facilities for prescription pharmaceuticals in Canada: in Laval, Quebec, and Steinbach, Manitoba. More information can be found at the Company's website at www.bauschhealth.ca. Forward-looking Statements This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words “will,” “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “subject to” and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law. REFERENCES 1 Bausch Health, Canada Inc., CABTREO Product Monograph,https://pdf.hres.ca/dpd_pm/00076715.PDF. 2 Canadian Dermatology Association, Acne, Quick Facts,https://dermatology.ca/public-patients/skin/acne/#:~:text=Acne%20affects%205.6%20million%20Canadians,adults%20ages%2020%20to%2040, accessed Aug. 20, 2024. 3 "What to Know about Hyperpigmentation Acne." Medical News Today, Jessica Caporuscio, April 28, 2021, https://www.medicalnewstoday.com/articles/hyperpigmentation-acne, accessed Aug. 20, 2024. 4 Bausch Health, Canada Inc., Canadian Product List, https://bauschhealth.ca/products/canadian-product-list/.

Clinical ResultPhase 3Drug Approval

100 Deals associated with Adapalene

External Link

KEGG	Wiki	ATC	Drug Bank
D01112	Adapalene	D10AD03	DB00210

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Acne Vulgaris	United States	Galderma Laboratories LP	31 May 1996

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Photodamaged skin	Phase 3	Brazil	Galderma Brasil Ltda.	01 Jan 2013
Skin aging	Phase 3	Brazil	Galderma Brasil Ltda.	01 Jan 2013
Severe acne	Phase 3	United States	Galderma Holding SA	01 Aug 2008
Severe acne	Phase 3	Canada	Galderma Holding SA	01 Aug 2008
Atrophic acne scar	Phase 2	United States	Galderma Holding SA	01 Mar 2011

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03615768 (CACTUS, Pubmed) Manual	Phase 3	Acne Vulgaris	1,617	Adapalene-clindamycin gel	quvshqwmdy(dydgwpopun) = btfaozbetp temvxlzzqe (fwzushdtmm ) View more	Positive	01 Nov 2024
				Adapalene gel	quvshqwmdy(dydgwpopun) = fqyxktaifn temvxlzzqe (fwzushdtmm ) View more
NCT03615768 (CACTUS, Pubmed \| Dermatol Ther (Heidelb))	Phase 3	Acne Vulgaris	1,617	Adapalene-clindamycin gel	pdutfvtlva(zvsrhyaubl) = kolsagkwck ojnhkgnwon (fyystrttlz )	Positive	01 Nov 2024
				Adapalene gel	pdutfvtlva(zvsrhyaubl) = pegwvrbzyp ojnhkgnwon (fyystrttlz )
NCT00422240 (CTgov)	Phase 3	Acne Vulgaris	1,668	Adapalene/Benzoyl Peroxide (Adapalene/Benzoyl Peroxide Gel)	imfjonylor = rdymmpzung cvdgzibsim (vccljrnpup, weizpcddbn - qyampwjrma) View more	-	15 Apr 2024
				Adapalene Gel, 0.1% (Adapalene Gel, 0.1%)	imfjonylor = jvdumznvwa cvdgzibsim (vccljrnpup, qtwddazvhs - nqzsakoiek) View more
NCT00671749 (CTgov)	Phase 4	Acne Vulgaris	100	Differin+Duac	qxdpguibft(jpxjmundqy) = itheynbpca biblplijmp (rhlqxmzjuq, 24.43) View more	-	16 Mar 2016
NCT01213199 (CTgov)	Phase 2	Atrophic acne scar	20	Differin	wmyjzsacis(beewzenvls) = nzhdpzoavs dchsflkifx (wsseqpukse, 0.8) View more	-	23 Mar 2015
NCT00829049 (CTgov)	Phase 4	Acne Vulgaris	165	Tazarotene Cream 0.1% (Tazarotene Cream 0.1%)	qaclkrihbc(ntatluztsx) = qrcegasgyz nxuoayvmrs (kvnndrftcl, qwsftldzjg - hlyltishhi) View more	-	12 Sep 2012
				Adapalene (Adapalene Gel 0.3%)	qaclkrihbc(ntatluztsx) = nvvnizbcge nxuoayvmrs (kvnndrftcl, ouhtwtxwgl - utonmfnbjx) View more
NCT01231334 (CTgov)	Phase 4	Acne Vulgaris	286	adapalene+Dapsone (Aczone® Gel 5% Plus Differin® 0.3% Gel)	aygpxrgsop = qkasrnedkx dumjbmdpzc (bmeuffbkmt, ybmfqvltwv - ndluodcsdw) View more	-	27 Jul 2012
				Adapalene+Dapsone (Duac® Topical Gel Plus Differin® 0.3% Gel)	aygpxrgsop = gjggcciebp dumjbmdpzc (bmeuffbkmt, crkqnxoxhq - grspswnqlh) View more
NCT00971282 (CTgov)	Phase 4	Pruritus	30	Cetaphil+Differin (Cetaphil + Differin)	puhutmiwzs(fmwhsdbixd) = hbqxfzgxjv wstglmiaaz (aqdgnjzzrb, 0.7) View more	-	15 May 2012
				Differin (Differin Alone)	puhutmiwzs(fmwhsdbixd) = jstptmcnuz wstglmiaaz (aqdgnjzzrb, 0.7) View more
NCT01046396 (CTgov)	Phase 1	Skin Manifestations	69	adapalene (Differin® Cream 0.1%)	kcsdztuymo = evlgwrdoiv slzmmlupnm (mbhwscmhih, nhqfzlepdg - zyaguqqrqb) View more	-	09 May 2011
				adapalene lotion 0.1% (Differin® Lotion 0.1%)	kcsdztuymo = dvtjprpbaq slzmmlupnm (mbhwscmhih, gmbfnpfbql - nruafbagug) View more
NCT01046565 (CTgov)	Phase 1	Skin Manifestations	75	adapalene lotion 0.1% (Differin® Lotion 0.1%)	nversyedel = saefxplqka waxtvxjxwb (lezrwesamu, vjvjuswmfu - plmannwxes) View more	-	02 May 2011
				adapalene cream 0.1% (Differin® Cream 0.1%)	meqdpciywa = oqrgmczkjt vxqeikebsu (plxniomhvi, dvbdqkubho - rfzhxlneae) View more

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