Bioequivalence Study of Adapalene Gel 0.3% in Subjects With Facial Acne Vulgaris

NCT03650361 | Completed Phase 3 FDA Drug

• 1 other identifier: ADPG 1807
• Study Type: interventional
• Target: 755
• Locations: 2 countries
• Sites: 10

Brief Summary

To evaluate the therapeutic equivalence and safety of Adapalene Gel 0.3% (Aleor Dermaceuticals Limited, India) and Differin® (Adapalene) Gel 0.3% (Galderma Laboratories, LP USA) in the treatment of acne vulgaris.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Mean percent change from baseline to week 12 in the inflammatory (papules and pustules) and in the non-inflammatory (open and closed comedones) lesion counts

  Uses both modified intent-to-treat (mITT) and per protocol (PP) populations

  12 weeks

Secondary Outcomes (1)

• The secondary endpoint is the Investigator Global Assessment (IGA) score, expressed in terms of treatment success or failure.

  12 weeks

Study Arms (3)

Test Product

EXPERIMENTAL

Adapalene Gel 0.3% manufactured by Aleor Dermaceuticals Limited, applied for 84 days

Drug: Adapalene Gel 0.3%

Reference Product

ACTIVE COMPARATOR

Adapalene Gel 0.3%, , applied for 84 days

Drug: Differin 0.3% Topical Gel

Placebo Control

PLACEBO COMPARATOR

Vehicle of the test product, applied for 84 days

Drug: Adapalene Gel 0.3% Vehicle Placebo

Interventions

Adapalene Gel 0.3% DRUG

Treatment applied as a thin layer of the product to the entire face once a day in the evening for 84 days

Test Product

Differin 0.3% Topical Gel DRUG

Treatment applied as a thin layer of the product to the entire face once a day in the evening for 84 days

Reference Product

Adapalene Gel 0.3% Vehicle Placebo DRUG

Treatment applied as a thin layer of the product to the entire face once a day in the evening for 84 days

Placebo Control

Eligibility Criteria

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

You may qualify if:

• Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
• Subjects who are 18 years of age or older (up to the age of 40 inclusive) must have provided IRB approved written informed consent. Subjects ages 12 to 17 years of age inclusive must have provided IRB approved written assent; this written assent must be accompanied by an IRB approved written informed consent from the Subject's legally acceptable representative (i.e., parent or guardian). In addition, all Subjects or their legally acceptable representatives (i.e., parent or guardian) must sign a HIPAA authorization.
• Subjects must have a minimum ≥ 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), at baseline on the face. For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area. When counting facial acne lesions, it is important that all lesions be counted, including those present on the nose. Lesions involving the eyes, lip and scalp should be excluded from the count. Subjects may have acne lesions on other areas of the body which will also be excluded from the count, treatment, and the Investigator's Global Assessment (IGA) evaluation (e.g., on the back, chest and arms).
• Subjects must have a definite clinical diagnosis of acne vulgaris of severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA)
• Subjects must be willing to refrain from using all other topical acne medications or antibiotics during the 12-week treatment period for acne vulgaris, other than the Investigational Product.
• Female Subjects of childbearing potential (excluding women who are surgically sterilized or postmenopausal for at least 1 year), in addition to having a negative urine pregnancy test, must be willing to use an acceptable form of birth control from the day of the first dose administration to 30 days after the last administration of study drug. For the purpose of this study the following are considered acceptable methods of birth control: oral or injectable contraceptives, contraceptive patches, Depo-Provera® (stabilized for at least 3 months); NuvaRing® (vaginal contraceptive); Implanon™ (contraceptive implant) double barrier methods (e.g. condom and spermicide); IUD, or abstinence. If a subject who was abstinent becomes sexually active during the study, a 2nd acceptable method of birth control should be documented. A sterile sexual partner is NOT considered an adequate form of birth control. Hormonal contraceptives should not be initiated or changed during the study.
• All male Subjects must agree to use accepted methods of birth control with their partners, from the day of the first dose administration to 30 days after the last administration of study drug. Abstinence is an acceptable method of birth control. Female partners should use an acceptable method of birth control as described in the above Item Number 6.
• Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.
• Subjects must be in good health and free from any clinically significant disease, including but not limited to, conditions that may interfere with the evaluation of acne vulgaris. Such conditions include, but are not limited to the following: auto immune disease, rosacea; seborrheic dermatitis; perioral dermatitis; corticosteroid-induced acne; carcinoid syndrome; mastocytosis; acneiform eruptions caused by make-up, medication, facial psoriasis and facial eczema.
• Subjects who use make-up must have used the same brands/types of make-up for a minimum period of 14 days prior to study entry and must agree to not change make-up brand/type or frequency of use throughout the study.

You may not qualify if:

• Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
• Subjects with a history of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients, have a known hypersensitivity to adapalene and its excipients.
• Subjects with the 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, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
• Subjects with excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
• Subjects who have performed wax depilation of the face within 14 days prior to baseline.
• Subjects who have used within 6 months prior to baseline or use during the study of oral retinoids (e.g. Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
• Subjects who have used estrogens or oral contraceptives for less than 3 months prior to baseline; use of such therapy must remain constant throughout the study.
• Subjects who have used any of the following procedures on the face within 1 month prior to baseline or during the study :
• cryodestruction or chemodestruction,
• dermabrasion,
• photodynamic therapy,
• acne surgery,
• intralesional steroids, or
• X-ray therapy.
• Subjects who have used any of the following treatments within 1 month prior to baseline or during the study:

Sponsors & Collaborators

• Aleor Dermaceuticals Limited: lead
• Catawba Research, LLC: collaborator

Study Sites (10)

Unison Center for Clinical Trials

Sherman Oaks, California, 91403, United States

Location

Moore Clinical Research Institute, Inc.

Brandon, Florida, 33511, United States

Location

FXM Research Corp.

Miami, Florida, 33175, United States

Location

FXM Research Miramar

Miramar, Florida, 33027, United States

Location

Moore Clinical Research Institute, Inc.

Tampa, Florida, 33609, United States

Location

Moore Clinical Research Institute, Inc.

Tampa, Florida, 33618, United States

Location

Dermatology Consulting Services, PLLC

High Point, North Carolina, 27262, United States

Location

3A Research, LLC

El Paso, Texas, 79902, United States

Location

3A Research, LLC

El Paso, Texas, 79925, United States

Location

FXM Research International

Belize City, Belize

Location

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 Officials

• Venkata. K. R. CH. Hemanth Varma. P

  Aleor Dermaceuticals Limited

  STUDY DIRECTOR

Study Design

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

Model Details: Double (Participant, Investigator)

Study Record Dates

• First Submitted: August 26, 2018
• First Posted: August 28, 2018
• Study Start: September 17, 2018
• Primary Completion: February 16, 2019
• Study Completion: February 16, 2019
• Last Updated: April 26, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); US (9)