A Clinical Trial to Evaluate the Efficacy of Two Acne Treatments
Condition: Acne
MeSH terms: Acne Vulgaris
Intervention: Product A; Product B
Intervention description: Product A applied topically to the entire face or other affected area of the skin once daily; Product B applied topically to affected area of the skin 1 to 3 times daily
Intervention MeSH terms: Salicylic Acid; Adapalene; Salicylates
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 127.0
Sex: All
Minimum age: 21 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the efficacy of 2 acne treatments for 24 weeks of
      use in adult men and women with mild to moderate facial acne, at least 5 inflammatory
      lesions, and at least 10 - 100 non-inflammatory lesions.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Men and women age 21 to 45 years at the time of enrollment.

          2. Individuals with mild to moderate acne (score of 2-3 on FDA Investigator's Global
             Assessment Scale1) on the face.

          3. Individuals with at least 5 inflammatory lesions.

          4. Individuals with 10 - 100 non-inflammatory lesions.

          5. Fitzpatrick skin type I-VI

          6. Individuals willing to provide written informed consent including photo release,
             Health Insurance Portability and Accountability Act (HIPAA), and are able to read,
             speak,write, understand English.

          7. Willing to withhold all facial treatments during the course of the study

          8. Individuals of child bearing potential who use an acceptable method of contraception
             throughout the study.

          9. Subjects must be stable on any medication they are taking for at least 30 days.

        Key Exclusion Criteria:

          1. Individuals diagnosed with allergies to topical acne products.

          2. Individuals having a condition and/or disease of the skin that the Investigator deems
             inappropriate for participation.

          3. Women who are nursing, pregnant, or planning to become pregnant during the study.

          4. Individuals who have pre-existing or dormant dermatologic conditions on the face which
             in the opinion of the Investigator could interfere with the outcome of the study.

          5. Individuals using or who have used any systemic medication considered to affect the
             course of acne, specifically, but not exclusively antibiotics or steroids within the
             last 30 days prior to entry into the study.

          6. Individuals who are currently participating in another facial usage study or have
             participated in a clinical trial within 4 weeks prior to inclusion into the study.

          7. Individuals with any planned surgeries and/or invasive medical procedures during the
             course of the study.

          8. Individuals who started hormone replacement therapies (HRT) or hormones for birth
             control less than 3 months prior to study entry or who plan on starting, stopping, or
             changing doses of HRT or hormones for birth control during the study.

          9. Individuals with facial sunburn or excessive tanned facial skin or that are not
             willing to avoid daily sun exposure on the face and the use of tanning beds or sunless
             tanning products for the duration of the study.

         10. Individuals that are currently taking or have taken within the last 30 days oral or
             topical prescription medications for acne.