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

NCT01706263 | Completed Phase 4 Results

• 1 other identifier: 114551
• Study Type: interventional
• Target: 28
• 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 the efficacy and tolerability of MAXCLARITY II, an over the counter, topical benzoyl peroxide (BPO) product line, in subjects with acne.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Week 8

  Evaluator assessed the left and right side of the face as inflammatory (papules \[solid elevation of skin with no visible fluid\] and pustules \[small inflamed elevation of the skin that is filled with pus\]) and non-inflammatory (open \[blackheads\] and closed \[whiteheads\] comedones) and total lesions (sum of inflammatory and non-inflammatory lesion) for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face from hairline to the mandible (including forehead, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 8 was calculated as the value at Week 8 minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline was defined as Day 1 value .

  Baseline (Day 1) and Week 8

Secondary Outcomes (5)

• Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Weeks 1, 2, and 4

  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

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

• Percentage of Participants Who Improved by at Least One Grade on the ISGA

  Up to Week 8

• Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.

  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

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

Study Arms (1)

MAXCLARITY II

EXPERIMENTAL

MAXCLARITY II (2.5% BPO) Foam Cleanser and Foam Treatment and (0.5% Salicylic Acid) Toner Foam. Available over-the-counter.

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

Interventions

MAXCLARITY II (2.5% BPO) Foam Cleanser DRUG

Available over the counter.

MAXCLARITY II

MAXCLARITY II (2.5% BPO) Foam Treatment DRUG

Available over the counter.

MAXCLARITY II

MAXCLARITY II (0.5% Salicylic Acid) Toner Foam DRUG

Available over the counter.

MAXCLARITY II

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 24 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
• GlaxoSmithKline: collaborator

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: NA
• Masking: NONE
• 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: August 1, 2009
• Primary Completion: November 20, 2009
• Study Completion: November 20, 2009
• Last Updated: January 8, 2018
• Results First Posted: January 8, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share