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Clinical Endpoint Bioequivalence Study of Adapalene Gel 0.1%

Primary Purpose

Acne Vulgaris

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Adapalene 0.1% Gel

Differin 0.1% Topical Gel

Placebo

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

12 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Test Group

Reference Group

Placebo Group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Proportion of subjects with a clinical response as success or failure

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

Percentage of subjects who achieved at least 50 % reduction in lesion counts (inflammatory, non-inflammatory and total lesion count)

Full Information

NCT ID

NCT04329403

First Posted

March 30, 2020

Last Updated

June 24, 2020

Sponsor

Aurobindo Pharma Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04329403

Brief Title

Clinical Endpoint Bioequivalence Study of Adapalene Gel 0.1%

Official Title

Randomized, Double Blind, Placebo Controlled, Parallel Group Design, Three Arm, Multicentric Study to Evaluate the Efficacy and Safety of Topical Adapalene Gel, 0.1 % in Healthy Males and Nonpregnant Female Subjects With Acne Vulgaris

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Withdrawn

Why Stopped

Market reasons

Study Start Date

July 2020 (Anticipated)

Primary Completion Date

January 2021 (Anticipated)

Study Completion Date

May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aurobindo Pharma Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Vulgaris

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test Group

Arm Type

Experimental

Arm Description

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

Arm Title

Reference Group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo Group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Adapalene 0.1% Gel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Differin 0.1% Topical Gel

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Mean percent change from baseline in the inflammatory lesion count.

Description

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

Time Frame

12 weeks

Title

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

Description

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

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Proportion of subjects with a clinical response as success or failure

Description

Time Frame

12 weeks

Title

Change in lesion count

Description

Percentage of subjects who achieved at least 50 % reduction in lesion counts (inflammatory, non-inflammatory and total lesion count)

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

Learn more about this trial

Clinical Endpoint Bioequivalence Study of Adapalene Gel 0.1%

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