A Treatment Regimen for Student Athletes With Mild to Moderate Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Adapalene/benzoyl peroxide gel, 0.1%/2.5%; Cetaphil Acne Regimen
Intervention description: Topical AV therapy; Cleanse, Moisturize, and Protect
Intervention MeSH terms: Adapalene; Adapalene, Benzoyl Peroxide Drug Combination; Benzoyl Peroxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The goal of this study is to evaluate a complete topical acne regimen consisting of a
      prescription acne medication (Epiduo® Gel) and an acne-specific cleanser (Cetaphil®
      DermaControl™ Foam Wash) and moisturizer with sunscreen (Cetaphil® DermaControl™ Moisturizer
      SPF 30) for safety, efficacy and patient satisfaction in student athletes with acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and females aged 12 years and older who are actively participating in one of 14
             Texas University Interscholastic League (UIL) sanctioned athletic activities at the
             baseline visit (Baseball; Basketball; Cross Country; Football; Golf; Soccer; Softball;
             Swimming and Diving; Team Tennis; Tennis; Track and Field; Volleyball; and Wrestling).

          2. Subjects who agree to be photographed at each visit.

          3. Diagnosed with acne vulgaris by a BCD and eligible for treatment with Epiduo®
             (adapalene and benzoyl peroxide) Gel 0.1%/2.5% per PI.

          4. Female subjects must have a negative urine pregnancy test (UPT) at Baseline/Visit 1,
             must be willing to have this test performed at the clinic, and must agree to practice
             one form of effective methods of non-hormonal contraception for the duration of the
             study which include: abstinence, IUD (inserted 30 days prior to baseline),
             double-barrier method, bilateral tubal ligation, or vasectomized partner (at least 90
             days prior to baseline).

          5. A minimum of 20 but not more than 50 inflammatory (papules and pustules) lesions on
             the face (excluding the nose) and a minimum of 30 but not more than 100
             noninflammatory lesions (open comedones and closed comedones) on the face (excluding
             the nose).

          6. Agree to use the provided study products as their only acne treatment, facial wash and
             facial moisturizer for the duration of the study.

          7. Agree to refrain from temporary and permanent tattoos, paint, or other facial art
             (including, but not limited to piercings), cosmetic procedures and devices (including,
             but not limited to facial peels, microdermabrasion and Clarisonic®) on the face for
             the duration of the study.

          8. Subjects aged 12-17 must be willing to read and provide written informed
             consent/assent in conjunction with a parent/legal guardian who is able and willing to
             read and provide written consent prior to any study related procedure or subjects aged
             18 and older must be willing to read and provide written informed consent prior to any
             study related procedures.

          9. Subjects apprised of the Health Insurance Portability and Accountability Act of 1996
             (HIPAA) and applicable state Bill of Rights and are willing to share personal
             information and data, as verified by signing a written authorization at Screening.

         10. Subjects must be willing and able to attend study visits and fulfill dosing
             requirements.

         11. Subjects able to follow study instructions and likely to complete all required visits.
             In particular, subjects must agree to adhere to the visit schedule and be compliant
             with the treatment regimen.

        Exclusion Criteria:

          1. Subjects with nodules and cysts.

          2. Female subjects who are pregnant, nursing or planning a pregnancy during the study.

          3. Subjects with facial hair, abnormal pigmented vascular skin lesions, abnormal skin
             pigmentation, or body art (tattoos, permanent or temporary) on the face, which could
             interfere with subsequent evaluations of dermal responsiveness.

          4. Subjects with any systemic or dermatological disorder, a known history of allergies or
             other medical conditions, which in the opinion of the principal investigator/BCD,
             could interfere with the conduct of the study, interpretation of results or increase
             the risk of adverse reactions.

          5. Subjects with any known allergies to any of the ingredients listed on the study
             product labels (refer to study product"s PI and/or current labelling).

          6. Subjects who have participated in another interventional, investigational drug or
             device research study within 30 days of enrollment.

          7. Study site staff or sponsor staff, relatives of site staff or sponsor, or other
             individuals who would have access to the clinical study protocol.

          8. Subjects with a washout period less than 1 week for over-the-counter topical acne
             treatments (with active ingredients such as Benzoyl Peroxide, Salicylic Acid, Sulfur
             and Resorcinol), prescription topical acne treatment and topical corticosteroids, and
             use of cosmetic devices (such as Clarisonic® or similar) and less than 4 weeks for
             topical retinoids.

          9. Subjects with a washout period less than 4 weeks for systemic prescription acne
             treatment and systemic corticosteroids and less than 24 weeks for oral retinoids.

         10. Subjects with current sunburn, eczema, atopic dermatitis, perioral dermatitis,
             rosacea, or other topical conditions on the area to be treated.

         11. Subjects who are at risk in terms of precautions, warnings, and contra-indications
             (refer to the study product"s PI and current labelling).

         12. Subjects who foresee unprotected and intense UV exposure during the study (mountain
             sports, UV radiation, sunbathing, etc.).

         13. Subjects with any visible skin condition or facial hair that could interfere with the
             evaluations.

         14. Subjects taking or planning to take topical or systemic medications to treat acne
             during the course of the study.

         15. Subjects taking other medications, supplements, or non-prescription treatments that,
             in the opinion of the principal investigator/BCD, could interfere with the test
             results including any regimen of steroidal/non-steroidal anti-inflammatory drugs, or
             antihistamines, or anabolic steroids.

         16. Subjects currently under the treatment for asthma or diabetes (insulin-dependent
             only).

         17. Subjects with planned surgical or cosmetic procedures of the face during the course of
             the study.

         18. Subjects with a history of procedures such as microdermabrasion, chemical peels,
             intense pulsed light, fillers, Botox®, lasers, photodynamic therapy, red and blue
             light therapy, etc. in the last 90 days.