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A Treatment Regimen for Student Athletes With Mild to Moderate Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT02249104
Recruitment Status : Completed
First Posted : September 25, 2014
Results First Posted : May 26, 2016
Last Update Posted : May 26, 2016
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Tracking Information
First Submitted Date  ICMJE September 23, 2014
First Posted Date  ICMJE September 25, 2014
Results First Submitted Date  ICMJE March 18, 2016
Results First Posted Date  ICMJE May 26, 2016
Last Update Posted Date May 26, 2016
Study Start Date  ICMJE August 2014
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2016)
Mean Change From Baseline in Total Lesion Count [ Time Frame: Baseline and 8 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 23, 2014)
Change from baseline in total lesion count [ Time Frame: 8 weeks ]
Change History Complete list of historical versions of study NCT02249104 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2016)
  • Percent Change From Baseline in Total Lesion Count [ Time Frame: Baseline and 8 weeks ]
  • Mean Change From Baseline in Inflammatory Lesion Count [ Time Frame: Baseline and 8 weeks ]
  • Mean Change From Baseline in Non-inflammatory Lesion Count [ Time Frame: Baseline and 8 weeks ]
  • Percent Change From Baseline in Inflammatory Lesion Count [ Time Frame: Baseline and 8 weeks ]
  • Percent Change From Baseline in Non-inflammatory Lesion Count [ Time Frame: Baseline and 8 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2014)
  • Percent Change From Baseline in Total Lesion Count [ Time Frame: 8 weeks ]
  • Change and percent change from baseline in inflammatory lesion count [ Time Frame: 8 weeks ]
  • Change and percent change from baseline in non-inflammatory lesion count [ Time Frame: 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Treatment Regimen for Student Athletes With Mild to Moderate Acne Vulgaris
Official Title  ICMJE Epiduo® (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% Pump, Cetaphil® DermaControl™ Moisturizer SPF 30, and Cetaphil® DermaControl™ Foam Wash Regimen in Student Athletes With Mild to Moderate Acne Vulgaris
Brief 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.
Detailed Description The overall purpose of this study was to demonstrate lesion count reduction from baseline, subject satisfaction, and compliance with a regimen of adapalene BPO used in conjunction with a foam wash and moisturizer with sunscreen in student athletes. The study hypothesis was that this regimen would reduce total lesion count (inflammatory and noninflammatory) relative to baseline. The objective of this study was to evaluate the change in lesion count (total, inflammatory, and noninflammatory) in subjects using the CoMMPlete regimen.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: Adapalene/benzoyl peroxide gel, 0.1%/2.5%
    Topical AV therapy
    Other Name: Epiduo
  • Other: Cetaphil Acne Regimen
    Cleanse, Moisturize, and Protect
    Other Names:
    • Cetaphil DermaControl Foam Wash
    • Cetaphil DermaControl Moisturizer SPF 30
Study Arms  ICMJE Experimental: Acne treatment

Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily

Cetaphil Acne Regimen:

Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application

Cetaphil® DermaControl™ Foam Wash, at least twice daily

Interventions:
  • Drug: Adapalene/benzoyl peroxide gel, 0.1%/2.5%
  • Other: Cetaphil Acne Regimen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 10, 2015)
28
Original Estimated Enrollment  ICMJE
 (submitted: September 23, 2014)
35
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02249104
Other Study ID Numbers  ICMJE GLI.04.SPR.US10302
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Galderma Laboratories, L.P.
Study Sponsor  ICMJE Galderma Laboratories, L.P.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Edward Lain, MD Pflugerville Dermatology Clinical Research
PRS Account Galderma Laboratories, L.P.
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP