Clinical Endpoint Bioequivalence Study of Adapalene Gel 0.1%
Study Details
Study Description
Brief Summary
To evaluate the therapeutic equivalence of topical Adapalene Gel, 0.1 % and Differin®(Adapalene) Gel, 0.1 % in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Bio-Equivalence study with a clinical endpoint in the treatment of acne vulgaris comparing adapalene cream, 0.1% test product versus the reference listed drug (RLD) and placebo (vehicle) control, each administered as one application once a day in the evening for 12 weeks
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Test Group Adapalene Gel, 0.1%, applied as thin film once daily for 12 weeks |
Drug: Adapalene 0.1% Gel
A thin film of the assigned medication to be applied once daily in the evening for 12 weeks
|
| Active Comparator: Reference Group Differin® (Adapalene) Gel, 0.1%, applied as thin film once daily for 12 weeks |
Drug: Differin 0.1% Topical Gel
A thin film of the assigned medication to be applied once daily in the evening for 12 weeks
|
| Placebo Comparator: Placebo Group Placebo Gel, 0.1%, applied as thin film once daily for 12 weeks |
Other: Placebo
A thin film of the assigned medication to be applied once daily in the evening for 12 weeks
|
Outcome Measures
Primary Outcome Measures
- Mean percent change from baseline in the inflammatory lesion count. [12 weeks]
Mean percent change compared to baseline inflammatory lesion count (papules and pustules) at Day 84 in per protocol population.
- Mean percent change from baseline in the non-inflammatory lesion count. [12 weeks]
Mean percent change compared to baseline non-inflammatory lesion count (open and closed comedones) at Day 84 in per protocol population.
Secondary Outcome Measures
- Proportion of subjects with a clinical response as success or failure [12 weeks]
Success will be defined as IGA score that is at least 2 grades less than the baseline assessment. Failure is defined as an IGA score that is the same, higher or one grade lower than the baseline assessment.
- Change in lesion count [12 weeks]
Percentage of subjects who achieved at least 50 % reduction in lesion counts (inflammatory, non-inflammatory and total lesion count)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or nonpregnant, nonlactating female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris
-
On the face, ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤ 2 nodulocystic lesions (i.e., nodules and cysts)
-
Investigator's Global Assessment (IGA) of acne severity Grade 2, 3, or 4
-
Willing to refrain from use of all other topical acne medications or antibiotics during the 12-week treatment period
-
If female of childbearing potential, willing to use an acceptable form of birth control during the study
Exclusion Criteria:
-
Pregnant, breast feeding or planning a pregnancy
-
Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis)
-
Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris
-
History of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients
-
Use within 6 months prior to baseline or during the study of oral retinoids (e.g., Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed)
-
Use for less than 3 months prior to baseline of estrogens or oral contraceptives; use of such therapy must remain constant throughout the study
-
Use on the face within 1 month prior to baseline or during the study of 1) cryo destruction or chemo destruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, or 6) x-ray therapy
-
Use within 1 month prior to baseline or during the study of 1) systemic steroids, 2) systemic antibiotics, 3) systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout), or 4) systemic anti-inflammatory agents
-
Use within 2 weeks prior to baseline or during the study of 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations,
- topical anti-inflammatory agents, or 5) topical antibiotics
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Aurobindo Pharma Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR191-18