U0289-401: Eight week, Split-face, Study to Determine and Compare the Efficacy and Tolerability of MAXCLARITY™ II to PROACTIV™
Trial overview
Mean percent change in inflammatory lesion (IL), non-inflammatory lesion (NIL), and total lesion (TL) counts from baseline (BL) (Day 1) to week (Wk) 8.
Timeframe: BL (Day 1) and Wk 8
Mean percent change in IL count from BL (Day 1) to wks 1, 2 and 4
Timeframe: BL (Day1) to Wks 1, 2 and 4
Mean percent change in NIL count from BL (Day 1) to Wks 1, 2 and 4
Timeframe: BL (Day 1) to Wks 1, 2 and 4
Mean percent change in TL count from BL (Day 1) to Wks 1, 2 and 4
Timeframe: BL (Day 1) to Wks 1, 2 and 4
Mean change in Investigator’s Static Global Assessment (ISGA) from BL (Day 1) to Wks 1, 2, 4 and 8.
Timeframe: BL (Day 1) to Wks 1, 2, 4 and 8
Mean change in each of the evaluator tolerability assessments-Erythema
Timeframe: BL (Day 1) to Wks 1, 2, 4 and 8
Mean change in each of the evaluator tolerability assessments-Dryness
Timeframe: BL (Day 1) to Wks 1, 2, 4 and 8
Mean change in each of the evaluator tolerability assessments-Peeling
Timeframe: BL (Day 1) to Wks 1, 2, 4 and 8
Mean change in each of the participant tolerability assessments-Redness
Timeframe: BL (Day 1) to Wks 1, 2, 4 and 8
Mean change in each of the participant assessments of tolerability-Dryness
Timeframe: BL (Day 1) to Wks 1, 2, 4 and 8
Mean change in each of the participant assessments of tolerability-Burning
Timeframe: BL (Day 1) to Wks 1,2, 4 and 8
Mean change in each of the participant assessments of tolerability-Itching
Timeframe: BL (Day 1) to Wks 1, 2, 4 and 8
Mean change in each of the participant assessments of tolerability-Scaling
Timeframe: BL (Day 1) to Wks 1, 2, 4 and 8
Participation 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.
- 1. Female who is pregnant, trying to become pregnant, or breast feeding.
- 2. Has active or chronic skin allergies.
- 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.
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 12 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:
- 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.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.