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Adapalene

Generic Name
Adapalene
Brand Names
Cabtreo, Differin, Epiduo, Panoxyl, Tactupump
Drug Type
Small Molecule
Chemical Formula
C28H28O3
CAS Number
106685-40-9
Unique Ingredient Identifier
1L4806J2QF
Background

Acne vulgaris is a multifactorial disorder of the pilosebaceous unit involving increased sebum production, inflammation, and hyperproliferation/hyperkeratinization of the follicular infundibulum. It is also associated with Cutibacterium acnes (also known as Propionibacterium acnes). Adapalene is a third-generation topical retinoid used for the treatment of acne vulgaris. Adapalene has similar efficacy but a superior safety profile compared to tretinoin. Tazarotene is more efficacious than adapalene but is designated as pregnancy category X and hence is contraindicated in pregnant women. Adapalene can also be combined with benzoyl peroxide (BPO), which possesses bactericidal properties, and either adapalene alone, or adapalene BPO combination products, are commonly used to treat mild-to-severe acne.

Differin®, produced by Galderma Labs, was first granted FDA approval on May 31st, 1996, as a 0.1% adapalene topical solution. Differin was later made available as 0.1% gel, cream, or lotion, or 0.3% gel products. On December 8th, 2008, Galderma Labs gained FDA approval for Epiduo®, a 0.1% adapalene, 2.5% BPO combination gel.

Indication

Adapalene is indicated for the topical treatment of acne vulgaris in patients aged 12 and over. It is also indicated for acne vulgaris in combination with benzoyl peroxide and in a triple combination therapy with benzoyl peroxide and clindamycin.

Associated Conditions
Acne Vulgaris

The Effectiveness and Safety of Cleanser Containing Triethyl Citrate, Pyruvic Acid, Combination Cream Containing Triethyl Citrate, Ethyl Linoleate, GT Peptide-10, Salicylic Acid 0,5%, Zinc Lactate, Hyaluronic Acid and Spot Cream Containing Triethyl Citrate, Ethyl Linoleate, GT Peptide-10, Honokiol

Phase 3
Not yet recruiting
Conditions
Acne Vulgaris
Interventions
Drug: Cleanser
Drug: Combination cream
Drug: placebo cleanser
Drug: placebo cream combination
Drug: spot cream
Drug: placebo spot cream
First Posted Date
2025-01-15
Last Posted Date
2025-01-16
Lead Sponsor
Dr.dr.Irma Bernadette, SpKK (K)
Target Recruit Count
102
Registration Number
NCT06775314
Locations
🇮🇩

Rumah Sakit Pusat Angkatan Darat Gatot Soebroto, Jakarta, Jakarta Pusat, Indonesia

Vitamin D Supplementation in Acne

Not Applicable
Recruiting
Conditions
Acne Vulgaris
Interventions
First Posted Date
2023-11-21
Last Posted Date
2024-08-29
Lead Sponsor
HITEC-Institute of Medical Sciences
Target Recruit Count
58
Registration Number
NCT06141330
Locations
🇵🇰

Hitec-Ims, Islamabad, Punjab, Pakistan

Effect of New Topical Preparation for Treatment of Acne Vulgaris

Phase 2
Not yet recruiting
Conditions
Acne Vulgaris
Interventions
Drug: DAP-FLU ME
First Posted Date
2023-06-12
Last Posted Date
2023-06-13
Lead Sponsor
Mansoura University
Target Recruit Count
20
Registration Number
NCT05899699
Locations
🇪🇬

Amgad El-Sayed Salem, Mansoura, Egypt

Experience With Topical Acne Treatment

Early Phase 1
Recruiting
Conditions
Acne
Interventions
Drug: adapalene, benzoyl peroxide gel, and clindamycin phosphate gel every day.
First Posted Date
2022-10-17
Last Posted Date
2024-11-01
Lead Sponsor
Wake Forest University Health Sciences
Target Recruit Count
72
Registration Number
NCT05582434
Locations
🇺🇸

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States

MC RCT - BPO vs Adapalene

Phase 3
Withdrawn
Conditions
Molluscum Contagiosum
Interventions
First Posted Date
2022-09-13
Last Posted Date
2024-03-06
Lead Sponsor
University of Oklahoma
Registration Number
NCT05536882
Locations
🇺🇸

OU Health Department of Dermatology, Oklahoma City, Oklahoma, United States

Effectivity and Safety of Combination Cream of Salicylic Acid, Aqua Posae Filiformis, Niacinamide, Lipohydroxy Acid, Procerad and Zinc PCA

Phase 1
Active, not recruiting
Conditions
Acne Vulgaris
Interventions
Drug: Combination Cream
First Posted Date
2022-08-11
Last Posted Date
2023-04-06
Lead Sponsor
Dr.dr.Irma Bernadette, SpKK (K)
Target Recruit Count
284
Registration Number
NCT05497323
Locations
🇮🇩

Rumah Sakit Umum Daerah Dr. Moewardi, Surakarta, Jawa Tengah, Indonesia

🇮🇩

Rumah Sakit Umum Pusat Cipto Mangunkusumo, Jakarta, DKI Jakarta, Indonesia

🇮🇩

Rumah Sakit Pusat Angkatan Darat Gatot Soebroto, Jakarta, DKI Jakarta, Indonesia

and more 2 locations

Effects of Oral Zinc Gluconate Among Acne Vulgaris Patients

Phase 4
Completed
Conditions
Acne Vulgaris
Interventions
First Posted Date
2021-10-27
Last Posted Date
2022-05-11
Lead Sponsor
East Avenue Medical Center, Philippines
Target Recruit Count
23
Registration Number
NCT05096312
Locations
🇵🇭

East Avenue Medical Center, Quezon City, Metro Manila, Philippines

Plantar Wart Treatment Using Adapalene Gel

Early Phase 1
Withdrawn
Conditions
Plantar Wart
Interventions
First Posted Date
2021-04-01
Last Posted Date
2023-04-13
Lead Sponsor
University of Louisville
Registration Number
NCT04823845

A Study Comparing Adapalene Gel 0.1% and to Differin Gel in the Treatment of Acne Vulgaris

Early Phase 1
Completed
Conditions
Acne Vulgaris
Interventions
First Posted Date
2021-03-15
Last Posted Date
2021-04-01
Lead Sponsor
Taro Pharmaceuticals USA
Target Recruit Count
978
Registration Number
NCT04797793
Locations
🇺🇸

Catawba Research, LLC, Charlotte, North Carolina, United States

Clinical Endpoint Bioequivalence Study of Adapalene Gel 0.1%

Phase 3
Withdrawn
Conditions
Acne Vulgaris
Interventions
First Posted Date
2020-04-01
Last Posted Date
2020-06-26
Lead Sponsor
Aurobindo Pharma Ltd
Registration Number
NCT04329403
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