Last updated: 11/07/2018 07:52:51
8 Week Study to Evaluate and Compare the Efficacy and Tolerability of MAXCLARITY II and MURAD To Treat Acne
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: U0289-404: An Evaluator Blinded, 8 Week, Split Face Study to Evaluate and Compare the Efficacy and Tolerability of MAXCLARITYII and MURAD in Subjects with Acne
Trial description: 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 and compare the efficacy and tolerability of 2 over the counter, topical product lines for the treatment of acne: MAXCLARITY II Foam Cleanser (2.5% benzoyl peroxide [BPO]) plus Foam Treatment (2.5% BPO) and (0.5% Salicylic Acid) Toner Foam compared with MURAD Clarifying Cleanser (1.5% salicylic acid [SA]) plus Exfoliating Acne Treatment Gel (1% SA) and Skin Perfecting Lotion.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Mean percent change in inflammatory, non-inflammatory and total lesion counts from Baseline to Week 8.
Timeframe: Baseline and Week 8
Secondary outcomes:
Mean percent change in inflammatory, non-inflammatory and total lesion counts from Baseline to Week 1, 2 and 4.
Timeframe: Baseline and Week 1, 2, 4
Mean change in Investigator's Static Global Assessment (ISGA) from Baseline to Week 1, 2, 4 and 8
Timeframe: Baseline and Week 1, 2, 4, 8
Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) from Baseline to Weeks 1, 2, 4 and 8.
Timeframe: Baseline and Week 1, 2, 4, 8
Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) from Baseline to Weeks 1, 2, 4 and 8.
Timeframe: Baseline and Week 1, 2, 4, 8
Percentage of Participant who improved by at least one grade on the ISGA
Timeframe: Up to Week 8
Interventions:
Other: MAXCLARITY II (2.5% BPO) Foam Cleanser
Other: MAXCLARITY II (2.5% BPO) Foam Treatment
Other: MAXCLARITY II (0.5% Salicylic Acid) Toner Foam
Other: MURAD Clarifying Cleanser (1.5% SA)
Other: Exfoliating Acne Treatment Gel (1% SA)
Other: Skin Perfecting Lotion
Enrollment:
20
Observational study model:
Not applicable
Primary completion date:
2009-07-12
Time perspective:
Not applicable
Clinical publications:
Jennifer Gwazdauskas, Lawrence Green, and Leon Kircik. Phase IV MaxClarity with Proactiv or Murad manuscript. J Drugs Dermatol. 2013;12(2):180-185.
Medical condition
Acne Vulgaris
Product
SKF63828, benzoyl peroxide, benzoyl peroxide/salicylic acid
Collaborators
Not applicable
Study date(s)
September 2009 to December 2009
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
16 - 29 years
Accepts healthy volunteers
No
- 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 an active or chronic skin allergy.
Inclusion and exclusion criteria
Inclusion criteria:
- 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, characterized by at least 12 facial inflammatory lesions (papules and pustules) and/or noninflammatory lesions (open and closed comedones) on each half of the face (excluding nose and front hairline areas). 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:
Exclusion criteria:
- 1. Female who is pregnant, trying to become pregnant, or breast feeding. 2. Has an active or chronic skin allergy. 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. 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. 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)
No location data available.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-07-12
Actual study completion date
2009-07-12
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.
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