Evaluation of Irritation That Potentially Could be Caused by Two Facial Gels Applied to Opposite Sides of the Face
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Tretinoin Facial Gel; Adapalene/Benzoyl Peroxide Facial Gel
Intervention description: A marketed facial gel containing Tretinoin 0.04% is applied to one side of the face daily for three weeks.; A marketed facial gel containing Adapalene .1% and Benzoyl peroxide 2.5% is applied to the other side of the face daily for three weeks
Intervention MeSH terms: Adapalene; Adapalene, Benzoyl Peroxide Drug Combination; Tretinoin; Benzoyl Peroxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Enrollment: 162.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: acne; irritation; objective sensory methods

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.
    

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

          -  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