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Evaluation of Irritation by Two Facial Gels Applied to Opposite Sides of the Face

Primary Purpose

Acne Vulgaris

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Tretinoin gel

Adapalene and Benzoyl peroxide

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring acne, irritation, objective sensory methods

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Healthy volunteers
Before screening, subjects (or legally authorized representative) must read and sign the IRB approved Informed Consent Form (includes HIPPA and Photo release)
Subjects must have Fitzpatrick Skin Type I, II or III, and judged by the Investigator to have healthy skin
Subject's bilateral facial skin must be clear of any confounding irritation, rashes, acne, rosacea, etc. prior to the study
Subject must be free of systemic retinoids for at least 2 months
Subject must not be using any topical retinoids, systemic antibiotics, nicotinamide or systemic steroids for 1 month prior to study start
All other topical medications to face (e.g., steroids, antimicrobials, salicylic acid and benzoyl peroxide) and cosmetics containing retinols, AHA's and bleaching agents such as hydroquinone are to be discontinued at least 2 weeks prior to study initiation
Subjects will not apply any emollients and cosmetics to the facial area 24 hours prior to study initiation
Subject must not be planning to become pregnant or nursing before entering the study and during the study period. In addition if using birth control pills, subject must be stabilized for at least 2 months. If subject is of child bearing potential, subject must be using approved method of birth control. Approved methods are birth control pills, implants, patches or spermicide with condoms.

Exclusion Criteria:

Subjects who are pregnant or nursing
Subjects who have a grade 1 or more for facial erythema
Subjects who exhibit any skin condition (i.e., atopic dermatitis, seborrheic dermatitis, and psoriasis) or disease that may require concurrent therapy or may confound the evaluation of drug safety or efficacy
Subjects who have a history of hypersensitivity to any of the formulation components listed in Appendix 1.
Subjects who have received any experimental drug or used any experimental device 30 days prior to initiation of study therapy
Subjects who have excessive facial hair that may obstruct or hinder the evaluation of any reactions
Subjects who use any known photosensitizing agents
Subjects who presently have skin cancer or actinic keratosis on the face

Sites / Locations

Skin Study Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Two interventions in split-face model

Arm Description

Once daily use in a split face model: Tretinoin gel Adapalene Benzoyl peroxide

Outcomes

Primary Outcome Measures

Comparative Assessment of Facial Irritation and Cutaneous Effects.

Expert Grader Assessment, including cumulative scores for Erythema and Dryness on a scale of 0=none to 8=severe

Secondary Outcome Measures

Self Assessment of Burning/Stinging and Itching

Cumulative scores of Subjects' self assessment of burning/stinging and itching on a score from 0=none to 3=severe

Full Information

NCT ID

NCT00919191

First Posted

June 10, 2009

Last Updated

February 14, 2012

Sponsor

Bausch Health Americas, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00919191

Brief Title

Evaluation of Irritation by Two Facial Gels Applied to Opposite Sides of the Face

Official Title

An Investigator-Blind, Phase 4 Study Assessing the Facial Irritation Potential of Two Acne Treatment Products Using A Split-Face Model

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

April 2009 (undefined)

Primary Completion Date

May 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bausch Health Americas, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

A study to compare the skin irritation potential of two marketed gels for acne treatment, each applied to half of the face of healthy volunteers.

Detailed Description

At the Baseline Visit, following satisfaction of entry criteria and screening procedures, all subjects will be applying two products to their faces, each on one side only. The side of the face receiving each product is randomly assigned. One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for three consecutive weeks after washing with the same study-supplied facial wash. Subjects will return to the study center every weekday morning for evaluation and application of both study products. Applications done on the weekends, will be done at home by the subject. At each visit the subject will be scored for cutaneous treatment effects by a blinded evaluator. At baseline and at the end of each week, subjects will be photographed and have chromometer readings.

6. Conditions and Keywords

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

Acne Vulgaris

Keywords

acne, irritation, objective sensory methods

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Two interventions in split-face model

Arm Type

Experimental

Arm Description

Once daily use in a split face model: Tretinoin gel Adapalene Benzoyl peroxide

Intervention Type

Drug

Intervention Name(s)

Tretinoin gel

Other Intervention Name(s)

Retin-A Micro Gel 0.04% Pump

Intervention Description

Tretinoin gel 0.04% used once daily in a split-face model

Intervention Type

Drug

Intervention Name(s)

Adapalene and Benzoyl peroxide

Other Intervention Name(s)

Epiduo Gel

Intervention Description

Adapalene .1% and Benzoyl peroxide 2.5%

Primary Outcome Measure Information:

Title

Comparative Assessment of Facial Irritation and Cutaneous Effects.

Description

Expert Grader Assessment, including cumulative scores for Erythema and Dryness on a scale of 0=none to 8=severe

Time Frame

Daily, for 3 weeks

Secondary Outcome Measure Information:

Title

Self Assessment of Burning/Stinging and Itching

Description

Cumulative scores of Subjects' self assessment of burning/stinging and itching on a score from 0=none to 3=severe

Time Frame

Daily, for 3 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy volunteers Before screening, subjects (or legally authorized representative) must read and sign the IRB approved Informed Consent Form (includes HIPPA and Photo release) Subjects must have Fitzpatrick Skin Type I, II or III, and judged by the Investigator to have healthy skin Subject's bilateral facial skin must be clear of any confounding irritation, rashes, acne, rosacea, etc. prior to the study Subject must be free of systemic retinoids for at least 2 months Subject must not be using any topical retinoids, systemic antibiotics, nicotinamide or systemic steroids for 1 month prior to study start All other topical medications to face (e.g., steroids, antimicrobials, salicylic acid and benzoyl peroxide) and cosmetics containing retinols, AHA's and bleaching agents such as hydroquinone are to be discontinued at least 2 weeks prior to study initiation Subjects will not apply any emollients and cosmetics to the facial area 24 hours prior to study initiation Subject must not be planning to become pregnant or nursing before entering the study and during the study period. In addition if using birth control pills, subject must be stabilized for at least 2 months. If subject is of child bearing potential, subject must be using approved method of birth control. Approved methods are birth control pills, implants, patches or spermicide with condoms. Exclusion Criteria: Subjects who are pregnant or nursing Subjects who have a grade 1 or more for facial erythema Subjects who exhibit any skin condition (i.e., atopic dermatitis, seborrheic dermatitis, and psoriasis) or disease that may require concurrent therapy or may confound the evaluation of drug safety or efficacy Subjects who have a history of hypersensitivity to any of the formulation components listed in Appendix 1. Subjects who have received any experimental drug or used any experimental device 30 days prior to initiation of study therapy Subjects who have excessive facial hair that may obstruct or hinder the evaluation of any reactions Subjects who use any known photosensitizing agents Subjects who presently have skin cancer or actinic keratosis on the face

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ana Rossi, MD

Organizational Affiliation

Johnson & Johnson Consumer and Personal Products Worldwide

Official's Role

Study Director

Facility Information:

Facility Name

Skin Study Center

City

Broomall

State/Province

Pennsylvania

ZIP/Postal Code

19008

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

20684151

Citation

Leyden JJ, Nighland M, Rossi AB, Ramaswamy R. Irritation potential of tretinoin gel microsphere pump versus adapalene plus benzoyl peroxide gel. J Drugs Dermatol. 2010 Aug;9(8):998-1003.

Results Reference

result

Links:

URL

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Description

FDA's Drug Finder

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