U0289-402: An Open Label, 8 Week Study to Evaluate the Efficacy and Tolerability of MAXCLARITY II in Subjects With Acne

• Status: Completed
• Trial end date: 2009-11-20
• Target enrollment: 0
• Participant gender: All

Summary

One of the main success factors in acne therapy is user compliance with treatment, product cost, availability and ease of use. Poor compliance may translate into decreased efficacy (either not improving symptoms well enough or not improving symptoms fast enough), tolerability issues or adverse effects (eg, erythema, dryness, or peeling of the skin), a lack of understanding of the instructions for use, or product cost/availability. Whatever the reason, poor compliance translates to decreased efficacy and increased frustration on the part of the user.

The current study will evaluate the efficacy and tolerability of MAXCLARITY II, an over the counter, topical benzoyl peroxide (BPO) product line, in subjects with acne.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stiefel, a GSK Company
• Collaborator: GlaxoSmithKline
• Treatments: Salicylates; Salicylic Acid

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. Male or female aged from 16 to 29 years, inclusive, at time of consent. No more than 50% of the subjects at each site can be enrolled under the age of 20.

3. Mild facial acne vulgaris, characterized by at least 24 facial inflammatory lesions (papules and pustules) and/or noninflammatory lesions (open and closed comedones) on the face.

4. Able to complete the study and to comply with study instructions.

5. 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 subject 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. Subjects with surgical sterilization, including tubal sterilization or partner's vasectomy, must use a form of nonhormonal contraception. A barrier method or sterilization plus spermatocide is acceptable.

• Women who are not currently sexually active must agree to use a medically accepted method of contraception should she become sexually active while participating in the study.

Exclusion Criteria:

1. Female who is pregnant, trying to become pregnant, or breast feeding.

2. Has active or chronic skin allergies.

3. Has a history of acute or chronic disease that might interfere with or increase the risk of study participation.

4. Had skin cancer treatment in preceding 12 months.

5. Has damaged skin on facial areas (eg, sunburn, tattoo, or scar)

6. Had any medical procedure (eg, laser resurfacing, chemical peel, or plastic surgery) on facial areas in preceding 12 months.

7. Had any cosmetic procedure (eg, microdermabrasion) on facial areas within 8 weeks of the baseline visit.

8. Has any dermatological disorder that in the opinion of the investigator may interfere with the accurate evaluation of the subject's facial appearance.

9. Received any investigational drug or procedure within 28 days of the baseline visit or is scheduled to receive an investigational drug (other than the study products) or procedure during the study.

10. Currently using any medication that in the opinion of the investigator may affect the evaluation of the study products or place the subject at undue risk (including but not limited to asthma medications, oral steroids, rifampin, anticonvulsants, and St John's wart).

11. Has a history of known or suspected intolerance to any of the ingredients of the study products (ie, benzoyl peroxide).

12. Considered unable or unlikely to attend the necessary visits.

13. Live in the same household as currently enrolled subjects.

14. Employee of the investigator, a contract research organization, or Stiefel Laboratories who is involved in the study, or an immediate family member (partner, offspring, parents, siblings or sibling's offspring) of an employee involved in the study.