Overview

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

Status:
Completed
Trial end date:
2009-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Bausch Health Americas, Inc.
Valeant Pharmaceuticals International, Inc.
Treatments:
Adapalene
Adapalene, Benzoyl Peroxide Drug Combination
Benzoyl Peroxide
Tretinoin
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

- 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