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Evaluation of Irritation That Could be Caused 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

Adapalene Gel

Tretinoin Gel

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).
Subject 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 study start.
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

A J&J CPPW Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tretinoin and Adapalene gels

Arm Description

Adapalene facial gel and tretinoin facial gel applied daily for two weeks on opposite sides of the face (in a split-face model)

Outcomes

Primary Outcome Measures

Assessment of Facial Irritation and Cutaneous Effects

Cumulative daily weekday scores for two weeks on Expert Grader Assessments: Dryness (0-8, none-deep)and Erythema (0-8, none-severe) and Self-Assessments: Burning/Stinging (0-3, none-severe) and Itching (0-3, none-severe)

Secondary Outcome Measures

Full Information

NCT ID

NCT00714714

First Posted

July 10, 2008

Last Updated

February 14, 2012

Sponsor

Bausch Health Americas, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00714714

Brief Title

Evaluation of Irritation That Could be Caused 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

January 2008 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

February 2008 (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 on their faces, each on half face. The side of face receiving each product is randomly assigned. One group will use tretinoin facial gel on the left side and adapalene facial gel on the right side of the face daily for two 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 two consecutive weeks after washing with the same study-supplied facial wash. Subjects will return to the study center every weekday morning for evaluation and for the morning application of both study products. Study personnel will monitor application on the weekdays. There will be a daily clinical evaluation of skin irritation by a blinded dermatologist and by subjects. 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

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tretinoin and Adapalene gels

Arm Type

Experimental

Arm Description

Adapalene facial gel and tretinoin facial gel applied daily for two weeks on opposite sides of the face (in a split-face model)

Intervention Type

Drug

Intervention Name(s)

Adapalene Gel

Other Intervention Name(s)

Differin Gel .3%

Intervention Description

adapalene gel 0.3% topically applied daily in a split-face model for two weeks

Intervention Type

Drug

Intervention Name(s)

Tretinoin Gel

Other Intervention Name(s)

Retin-A MICRO Gel

Intervention Description

Tretinoin 0.1% topically applied daily in a split face model for two weeks

Primary Outcome Measure Information:

Title

Assessment of Facial Irritation and Cutaneous Effects

Description

Time Frame

cumulative daily weekday scores for two 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). Subject 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 study start. 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 B Rossi, MD

Organizational Affiliation

Johnson & Johnson Consumer & Personal Products Companies, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

A J&J CPPW Investigational Site

City

Broomall

State/Province

Pennsylvania

ZIP/Postal Code

19008

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

12243706

Citation

Nyirady J, Grossman RM, Nighland M, Berger RS, Jorizzo JL, Kim YH, Martin AG, Pandya AG, Schulz KK, Strauss JS. A comparative trial of two retinoids commonly used in the treatment of acne vulgaris. J Dermatolog Treat. 2001 Sep;12(3):149-57. doi: 10.1080/09546630152607880.

Results Reference

result

Links:

URL

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

Description

FDA's Drug Finder

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