Clinical Endpoint Bioequivalence Study of Adapalene Gel 0.1%

NCT ID: NCT04329403

Last Updated: 2020-06-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-31
• Study Completion Date: 2021-05-31

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.

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

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Test Group

Adapalene Gel, 0.1%, applied as thin film once daily for 12 weeks

Group Type: EXPERIMENTAL

Adapalene 0.1% Gel

Intervention Type: DRUG

A thin film of the assigned medication to be applied once daily in the evening for 12 weeks

Reference Group

Differin® (Adapalene) Gel, 0.1%, applied as thin film once daily for 12 weeks

Group Type: ACTIVE_COMPARATOR

Differin 0.1% Topical Gel

Intervention Type: DRUG

A thin film of the assigned medication to be applied once daily in the evening for 12 weeks

Placebo Group

Placebo Gel, 0.1%, applied as thin film once daily for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

A thin film of the assigned medication to be applied once daily in the evening for 12 weeks

Interventions

Adapalene 0.1% Gel

A thin film of the assigned medication to be applied once daily in the evening for 12 weeks

Intervention Type: DRUG

Differin 0.1% Topical Gel

A thin film of the assigned medication to be applied once daily in the evening for 12 weeks

Intervention Type: DRUG

Placebo

A thin film of the assigned medication to be applied once daily in the evening for 12 weeks

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Male or nonpregnant, nonlactating female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris

2. 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)

3. Investigator's Global Assessment (IGA) of acne severity Grade 2, 3, or 4

4. Willing to refrain from use of all other topical acne medications or antibiotics during the 12-week treatment period

5. If female of childbearing potential, willing to use an acceptable form of birth control during the study

Exclusion Criteria

1. Pregnant, breast feeding or planning a pregnancy

2. 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)

3. Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris

4. History of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients

5. 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)

6. Use for less than 3 months prior to baseline of estrogens or oral contraceptives; use of such therapy must remain constant throughout the study

7. 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

8. 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

9. 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, 4) topical anti-inflammatory agents, or 5) topical antibiotics

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aurobindo Pharma Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CR191-18

Identifier Type: -

Identifier Source: org_study_id