Last updated: 11/07/2018 07:52:16

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

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GSK study ID
114551
See study documents
Clinicaltrials.gov ID
NCT01706263
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: U0289-402: An Open Label, 8 Week Study to Evaluate the Efficacy and Tolerability of MAXCLARITY II 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 the efficacy and tolerability of MAXCLARITY II, an over the counter, topical benzoyl peroxide (BPO) product line, in subjects with acne.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Mean percent change in inflammatory, non inflammatory, and total lesion counts from Baseline to Week 8

Timeframe: Baseline (Day 1) and Week 8

Secondary outcomes:

Mean percent change in inflammatory, non inflammatory, and total lesion counts from Baseline to Weeks 1, 2, and 4

Timeframe: Baseline (Day 1) and Week 1, 2, 4

Mean change in Investigator's Static Global Assessment (ISGA) from baseline to weeks 1, 2, 4 and 8

Timeframe: Baseline (Day 1) and Week 1, 2, 4, 8

Percentage of participants who improved by at least one grade on the ISGA

Timeframe: Up to Week 8

Change in investigator assessment of tolerability (erythema, dryness and peeling) from Baseline to Weeks 1, 2, 4 and 8.

Timeframe: Baseline (Day 1) 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 (Day 1) and Week 1, 2, 4, 8

Interventions:
  • Drug: MAXCLARITY II (2.5% BPO) Foam Cleanser
  • Drug: MAXCLARITY II (2.5% BPO) Foam Treatment
  • Drug: MAXCLARITY II (0.5% Salicylic Acid) Toner Foam
    • Enrollment:
    28
    Primary completion date:
    2009-20-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Jennifer Gwazdauskas, Leon Kircik, Lawrence Green, Victoria Butners. Phase IV MaxClarity efficacy, safety, and tolerability manuscript. J Drugs Dermatol. 2013;12(3):259-264.
    Medical condition
    Acne Vulgaris
    Product
    SKF63828, benzoyl peroxide, benzoyl peroxide/salicylic acid
    Collaborators
    GSK
    Study date(s)
    August 2009 to November 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 active or chronic skin allergies.
    Inclusion and exclusion 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.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
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    Scientific result summary
    Available language(s): English
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    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2009-20-11
    Actual study completion date
    2009-20-11

    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.

    Additional information about the trial

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