Evaluation of Irritation That Could be Caused by Two Facial Gels Applied to Opposite Sides of the Face.

NCT00714714 | Completed Phase 4 Results

• 1 other identifier: CA-P-5893
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Keywords

acne; irritation; objective sensory methods

Outcome Measures

Primary Outcomes (1)

• 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)

  cumulative daily weekday scores for two weeks

Study Arms (1)

Tretinoin and Adapalene gels

EXPERIMENTAL

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

Drug: Adapalene Gel; Drug: Tretinoin Gel

Interventions

Adapalene Gel DRUG

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

Also known as: Differin Gel .3%

Tretinoin and Adapalene gels

Tretinoin Gel DRUG

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

Also known as: Retin-A MICRO Gel

Tretinoin and Adapalene gels

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (1)

A J&J CPPW Investigational Site

Broomall, Pennsylvania, 19008, United States

Location

Related Publications (1)

• 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.

  PMID: 12243706 RESULT

Related Links

• FDA's Drug Finder

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Tretinoin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Results Point of Contact

• Title: David Lineberry, Associate Director Clinical Operations
• Organization: Valeant Pharmaceuticals International, Inc

David.Linberry@valeant.com

949-973-1153

Study Officials

• Ana B Rossi, MD

  Johnson & Johnson Consumer & Personal Products Companies, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2008
• First Posted: July 14, 2008
• Study Start: January 1, 2008
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: February 15, 2012
• Results First Posted: September 2, 2009

Record last verified: 2012-02

Locations

US (1)