U0289-401: Eight Week, Split-face, Study to Determine and Compare the Efficacy and Tolerability of MAXCLARITY™ II to PROACTIV™

NCT01706250 | Completed Phase 4 Results

• 1 other identifier: 114550
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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 and compare the efficacy and tolerability of 2 over-the-counter, topical benzoyl peroxide (BPO) product lines in subjects with acne: MAXCLARITY II (2.5% BPO) Foam Cleanser and Foam Treatment and (0.5% Salicylic Acid) Toner Foam compared with PROACTIV (2.5% BPO) Renewing Cleanser and Repairing Lotion and Revitalizing Toner.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• 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.

  This was an efficacy variable. An expert grader evaluated each side of the face (included forehead, cheeks and chin), the left and the right side, for IL (presence of papules and pustules), NIL (presence of open and closed comedones) and the TLs. The mouth, nose, periocular area, nasogenian, and superior and inferior eyelids were excluded. The evaluator was also blinded. BL was defined as Day 1. The percent change was calculated as the value at Wk 8 minus the value at BL.

  BL (Day 1) and Wk 8

Secondary Outcomes (12)

• Mean Percent Change in IL Count From BL (Day 1) to Wks 1, 2 and 4

  BL (Day1) to Wks 1, 2 and 4

• Mean Percent Change in NIL Count From BL (Day 1) to Wks 1, 2 and 4

  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

  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.

  BL (Day 1) to Wks 1, 2, 4 and 8

• Mean Change in Each of the Evaluator Tolerability Assessments-Erythema

  BL (Day 1) to Wks 1, 2, 4 and 8

Study Arms (2)

MAXCLARITY II

EXPERIMENTAL

MaxClarity II (2.5% BPO) Foam Cleanser and Foam Treatment and (0.5% Salicylic Acid) Toner Foam. Available over the counter. Each subject applies both arms (MaxClarity II and Proactiv) simultaneously for the entire duration of the study (8 weeks), each arm to be applied to one side of the face only (split-face study) according to randomization.

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

PROACTIV

ACTIVE COMPARATOR

Proactiv (2.5% BPO) Renewing Cleanser and Repairing Lotion and Revitalizing Toner. Available over the counter. Each subject applies both arms (MaxClarity II and Proactiv) simultaneously for the entire duration of the study (8 weeks), each arm to be applied to one side of the face only (split-face study) according to randomization.

Other: PROACTIV (2.5% BPO) Renewing Cleanser; Other: PROACTIV (2.5% BPO) Repairing Lotion; Other: PROACTIV (2.5% BPO) Revitalizing Toner

Interventions

MAXCLARITY II (2.5% BPO) Foam Cleanser OTHER

Available over the counter.

MAXCLARITY II

MAXCLARITY II (2.5% BPO) Foam Treatment OTHER

Available over the counter.

MAXCLARITY II

MAXCLARITY II (0.5% Salicylic Acid) Toner Foam OTHER

Available over the counter.

MAXCLARITY II

PROACTIV (2.5% BPO) Renewing Cleanser OTHER

Available over the counter.

PROACTIV

PROACTIV (2.5% BPO) Repairing Lotion OTHER

Available over the counter.

PROACTIV

PROACTIV (2.5% BPO) Revitalizing Toner OTHER

Available over the counter.

PROACTIV

Eligibility Criteria

• Age: 16 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Female who is pregnant, trying to become pregnant, or breast feeding.
• Has active or chronic skin allergies.
• Has a history of acute or chronic disease that might interfere with or increase the risk of study participation.
• Had skin cancer treatment in preceding 12 months.
• Has damaged skin on facial areas (eg, sunburn, tattoo, or scar)
• Had any medical procedure (eg, laser resurfacing, chemical peel, or plastic surgery) on facial areas in preceding 12 months.
• Had any cosmetic procedure (eg, microdermabrasion) on facial areas within 8 weeks of the baseline visit.
• Has any dermatological disorder that in the opinion of the investigator may interfere with the accurate evaluation of the subject's facial appearance.
• 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.
• 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).
• Has a history of known or suspected intolerance to any of the ingredients of the study products (ie, benzoyl peroxide).
• Considered unable or unlikely to attend the necessary visits.
• Live in the same household as currently enrolled subjects.
• 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.

Sponsors & Collaborators

• Stiefel, a GSK Company: lead

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Salicylic Acid

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2012
• First Posted: October 15, 2012
• Study Start: September 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 25, 2010
• Last Updated: August 23, 2017
• Results First Posted: June 20, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share