A Five Day Clinical Study to Examine the Effects of a Benzoyl Peroxide Treatment on Facial Acne Lesions
Condition: Skin Diseases
MeSH terms: Skin Diseases
Intervention: 3% Benzoyl Peroxide; 3% Benzoyl Peroxide Placebo; Neutrogena Rapid Clear®
Intervention description: Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.; The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.; A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
Intervention MeSH terms: Benzoyl Peroxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 90.0
Sex: All
Minimum age: 12 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      5 Day study to assess how quickly a topical acne product begins to work.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Capable of understanding and willing to provide signed and dated written voluntary
             informed consent (and any local or national authorization requirements) before any
             protocol specific procedures are performed.

          2. Fitzpatrick Skin Type I - V.

          3. Male or female aged from 12 to 45 years, inclusive, at time of consent.

          4. Mild to moderate facial acne vulgaris as determined by the Investigator, with a
             minimum of 10 inflammatory lesions (papules plus pustules, including nasal lesions)
             and a minimum of 10 non-inflammatory lesions (open and closed comedones, including
             nasal lesions).

          5. Three appropriate and evaluable target lesions, as judged by the Investigator.

          6. Able to complete the study and to comply with study instructions.

          7. Sexually active females of childbearing potential participating in the study must
             agree to use a medically acceptable method of contraception while receiving
             protocol-assigned product. A woman of childbearing potential is defined as one who is
             biologically capable of becoming pregnant; including perimenopausal women who are less
             than 2 years from their last menses. Acceptable contraceptive methods include the
             following:

               -  Hormonal contraception, including oral, injectable, or implantable methods
                  started at least 2 months prior to screening. If hormonal contraception was
                  started less than 2 months prior to screening, then a form of nonhormonal
                  contraception should be added until the third continuous month of hormonal
                  contraception has been completed.

               -  Two forms of reliable nonhormonal contraception, to include the use of either an
                  intrauterine device plus a reliable barrier method or 2 reliable barrier methods.
                  Reliable barrier methods include condoms or diaphragms. A cervical cap is also a
                  reliable barrier method, provided that the female participant has never given
                  birth naturally. The combined use of a condom and spermicide constitute 2 forms
                  of acceptable nonhormonal contraception, provided that they are both used
                  properly. The use of spermicide alone and the improper use of condoms are
                  inferior methods of contraception. Participants with surgical sterilization,
                  including tubal sterilization or partner's vasectomy, must use a form of
                  nonhormonal contraception. A barrier method or sterilization plus spermicide is
                  acceptable.

               -  Women who are not currently sexually active must agree to use a medically
                  accepted method of contraception should they become sexually active while
                  participating in the study.

        Exclusion Criteria:

          1. Has any nodulocystic lesions at the baseline evaluation.

          2. Female who is pregnant, trying to become pregnant, or breastfeeding.

          3. Has active or chronic skin allergies.

          4. Has a history of acute or chronic disease that might interfere with or increase the
             risk of study participation.

          5. Had skin cancer treatment in preceding 12 months.

          6. Has damaged skin on facial areas (e.g., sunburn, tattoo, or scar).

          7. Had any medical procedure (e.g., laser resurfacing, chemical peel, or plastic surgery)
             on facial areas in preceding 12 months.

          8. Had any cosmetic procedure (e.g., microdermabrasion) on facial areas within 8 weeks of
             the baseline visit.

          9. Has any dermatological disorder that in the opinion of the Investigator may interfere
             with the accurate evaluation of the participant's facial appearance.

         10. Received any investigational drug or procedure within 28 days of study day 1 or is
             scheduled to receive an investigational drug (other than the study products) or
             procedure during the study.

         11. Currently using any medication that in the opinion of the Investigator may affect the
             evaluation of the study products or place the participant at undue risk.

         12. Has a history of known or suspected intolerance to any of the ingredients of the study
             products (i.e., benzoyl peroxide).

         13. Considered unable or unlikely to attend the necessary visits.

         14. Has used non-steroidal anti-inflammatory drugs for the treatment of acne or for
             treatment durations longer than 7 days for any condition.

         15. Uses oil-based sunscreens or sunscreens containing active ingredients that may have an
             effect on acne.

         16. Has received treatment with estrogens (including oral, implanted, and topical
             contraceptives), androgens, or anti-androgenic agents for 12 weeks or less immediately
             prior to starting application of the study product. Participants who have been treated
             with estrogens, as described above, androgens, or anti-androgenic agents for more than
             12 consecutive weeks prior to starting application of the study product are allowed to
             enroll as long as they do not expect to change dose, drug, or discontinue use during
             the study.

         17. Has used topical antibiotics on the face or use of systemic antibiotics within the
             previous 2 weeks.

         18. Has used topical anti-acne medications (e.g., BPO, azelaic acid, resorcinol,
             salicylates) within the previous 2 weeks.

         19. Has used topical corticosteroids on the face or systemic corticosteroids within the
             previous 4 weeks. Use of inhaled, intra-articular or intra-lesional steroids other
             than for facial acne is acceptable.

         20. Has used systemic retinoids within the previous 6 months or topical retinoids within
             the previous 6 weeks.

         21. Uses abradants, facials, peels containing glycolic or other acids; masks, washes or
             soaps containing BPO, salicylic acid, or sulfacetamide sodium; non-mild facial
             cleansers, or moisturizers that contain retinol, salicylic acid or α- or β-hydroxy
             acids.

         22. Uses medications known to exacerbate acne (e.g., mega-doses of vitamin D [>2000
             IU/day] and vitamin B12 [>1 mg/day]; systemic steroids; androgens; haloperidol;
             halogens such as iodide and bromide; lithium; hydantoin; and phenobarbital).

         23. Has had any facial procedure (e.g., blue light, chemical or laser peel,
             microdermabrasion) performed by any practitioner within 4 weeks before the study
             started or during the course of the study.