Clinical Endpoint Bioequivalence Study of Adapalene Gel 0.1%

NCT04329403 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: CR191-18
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

• Mean percent change from baseline in the inflammatory lesion count.

  Mean percent change compared to baseline inflammatory lesion count (papules and pustules) at Day 84 in per protocol population.

  12 weeks

• Mean percent change from baseline in the non-inflammatory lesion count.

  Mean percent change compared to baseline non-inflammatory lesion count (open and closed comedones) at Day 84 in per protocol population.

  12 weeks

Secondary Outcomes (2)

• Proportion of subjects with a clinical response as success or failure

  12 weeks

• Change in lesion count

  12 weeks

Study Arms (3)

Test Group

EXPERIMENTAL

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

Drug: Adapalene 0.1% Gel

Reference Group

ACTIVE COMPARATOR

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

Drug: Differin 0.1% Topical Gel

Placebo Group

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Adapalene 0.1% Gel DRUG

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

Test Group

Differin 0.1% Topical Gel DRUG

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

Reference Group

Placebo OTHER

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

Placebo Group

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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, 4) topical anti-inflammatory agents, or 5) topical antibiotics

Sponsors & Collaborators

• Aurobindo Pharma Ltd: lead

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Adapalene; Gels

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 1, 2020
• Study Start: July 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: May 1, 2021
• Last Updated: June 26, 2020

Record last verified: 2020-06