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U0289-405: An Open-Label, 12-Week Study to Evaluate the Efficacy and Safety of the Acne System (Benzoyl Peroxide 2.5%, Salicylic Acid 0.5%) in Subjects With Acne

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:
NCT01446237
First received: July 28, 2011
Last updated: November 30, 2016
Last verified: November 2016
  Purpose
This study is being conducted to obtain safety, efficacy, and satisfaction data on the combination of topical Benzoyl Peroxide (BPO) 2.5% and the topical keratolytic agent Salicylic Acid (SA) 0.5% in the treatment of moderate to severe acne. Subjects with moderate or severe acne will be asked to apply the commercially available, over-the-counter products Foam Deep Cleanser (2.5% BPO), Foam Advanced Acne Treatment (2.5% BPO), and Foam Rejuvenating Toner (0.5% SA) daily for 12 weeks. No control group or reference treatment will be included.

Condition Intervention
Acne Vulgaris
Other: acne system - benzoyl peroxide 2.5%, Salicyclic Acid 0.5%

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, 12-Week Study to Evaluate the Efficacy and Safety of the Acne System (Benzoyl Peroxide 2.5%, Salicylic Acid 0.5%) in Subjects With Acne

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The mean percent changes in inflammatory (IL), non-inflammatory (NIL), and total lesion (TL) counts from Baseline to each study visit [ Time Frame: baseline and Upto Week 1, 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
  • Number of participants with a minimum 2-grade improvement of ISGA from Baseline to each study visit [ Time Frame: baseline and Upto Week 1, 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
  • Number of participants with ISGA score of 0 (clear) or 1 (almost clear) at each study visit [ Time Frame: Week 1, 2, 4, 8 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absolute change in inflammatory, non-inflammatory, and total lesion count from Baseline to each study visit [ Time Frame: Baseline and Upto Week 1, 2, 4, 8, 12 ] [ Designated as safety issue: No ]
  • Mean change in ISGA from Baseline to each study visit. [ Time Frame: Baseline and Upto Week 1, 2, 4, 8, 12 ] [ Designated as safety issue: No ]
  • Mean change from baseline in Post-inflammatory hyperpigmentation Severity at week 1, 2, 4, 8, 12 [ Time Frame: Baseline and Upto Week 1, 2, 4, 8, 12 ] [ Designated as safety issue: No ]
  • Mean change from baseline in Post-inflammatory hyperpigmentation distribution at week 1, 2, 4, 8, 12 [ Time Frame: Baseline and Upto Week 1, 2, 4, 8, 12 ] [ Designated as safety issue: No ]
  • Assessment of Subject's Global Improvement Scale [ Time Frame: Week 1, 2, 4, 8, 12 ] [ Designated as safety issue: No ]

Enrollment: 125
Study Start Date: June 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acne system - benzoyl peroxide 2.5%, Salicylic Acid 0.5%
open label - no comparator; only Acne system - benzoyl peroxide 2.5%, Salicylic Acid 0.5%
Other: acne system - benzoyl peroxide 2.5%, Salicyclic Acid 0.5%
over the counter acne system

Detailed Description:
This open-label, multicenter, study is being conducted to obtain safety, efficacy, and satisfaction data on an Acne System (Benzoyl Peroxide 2.5%, Salicylic Acid 0.5%), which includes Foam Deep Cleanser (2.5% Benzoyl Peroxide) and Foam Advanced Acne Treatment (2.5% Benzoyl Peroxide) and Foam Rejuvenating Toner (0.5% Salicylic Acid), in the treatment of moderate to severe acne. Approximately 120 male or female subjects ages 12-35 years, inclusive, with moderate or severe acne as assessed by Investigator's Global Assessment (ISGA) and lesion counts are expected to be enrolled. Subjects will be instructed to use all 3 study products as part of a complete acne treatment system; no reference therapy or control group will be included. Subjects will be instructed to apply Foam Deep Cleanser (2.5% Benzoyl Peroxide) and Foam Advnced Acne Treatment (2.5% Benzoyl Peroxide) to the face each morning and Foam Deep Cleanser (2.5% Benzoyl Peroxide) and Foam Rejuvenating Toner (0.5% Salicylic Acid) each evening over an application period of 12 weeks.
  Eligibility

Ages Eligible for Study:   12 Years to 35 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 ages 12 to 35 years, inclusive at time of consent.
  • ISGA score of 3 or 4 at Baseline.
  • Lesion counts meeting all of the following criteria: A: A minimum of 25 but not more than 50 facial inflammatory lesions (papules and pustules), excluding nasal lesions. B: A minimum of 20 but not more than 100 facial non-inflammatory lesions (open and closed comedones), excluding nasal lesions. C: No more than 3 facial nodular lesions (<5mm), with no cystic lesions.
  • Ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
  • Negative urine pregnancy test for females of childbearing potential.
  • 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.

Exclusion Criteria:

  • Female who is pregnant, trying to become pregnant, or breast feeding.
  • History of lupus, dermatomyositis, rosacea, seborrheic dermatitis, beard folliculitis, polycystic ovary syndrome, hirsutism, or perioral dermatitis. (Subjects with Seborrheic dermatitis may be enrolled if the condition has been inactive for at least 1 year and/or it does not affect the face.)
  • Use of topical antibiotics on the face within the past 2 weeks or of systemic antibiotics for acne treatment within the past 4 weeks.
  • Concurrent use of medications known to be photosensitizers (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, and sulfonamides) because of the possibility of augmented photosensitivity.
  • Use of topical corticosteroids on the face within the past 2 weeks or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular, or intra-lesional steroids other than for facial acne is acceptable.
  • Use of systemic retinoids (eg, isotretinoin) within the past 6 months.
  • Treatment with estrogens, including oral, implanted, injected, and topical contraceptives, androgens, or anti-androgenic agents for 12 weeks or fewer immediately prior to study enrollment. Subjects that have been treated with estrogens, as described above, androgens, or anti-androgenic agents for more than 12 consecutive weeks prior to study enrollment are allowed to enroll as long as they do not expect to change the dose or drug, or to discontinue use during the study and it has not been indicated for the treatment of acne vulgaris.
  • Male with facial hair that could interfere with study assessments.
  • Use of topical anti-acne medications (eg, BPO, retinoids, azelaic acid, resorcinol, sulfur and derivatives, SA, alpha or beta hydroxy acids, antioxidants, anti-wrinkle, antimicrobials, glycolic acid, abradants) within the past 2 weeks. Use of superficial facial procedures, and natural/herbal products within the past 4 weeks.
  • Concomitant use of medications that are reported to exacerbate acne as these may impact efficacy assessments.
  • Facial procedure (eg, blue light, chemical or laser peel, microdermabrasion) performed by aesthetician, beautician, physician, nurse, or other practitioner within the past 8 weeks.
  • facial skin cancer diagnosis in preceding 12 months.
  • Require or desire excessive or prolonged exposure to ultraviolet light (eg, sunlight or tanning beds) during the study.
  • Dermatological disorder that in the opinion of the investigator may interfere with the accurate evaluation of the subject's facial appearance.
  • Any major illness within 4 weeks before study enrollment.
  • Previous use of the study products.
  • Use of any investigational drug or procedure within the past 4 weeks or currently participating in another clinical study.
  • Known hypersensitivity or previous allergic reaction to any of the active components of the study product.
  • Any other condition which, in the judgement of the investigator, would put the subject at unacceptable risk for participation in the study.
  • Current drug or alcohol abuse. (Drug screening is not required.)
  • Considered unable or unlikely to attend the necessary visits.
  • Employee of the investigator, clinical research organization, Stiefel, a GSK company, or GlaxoSmithKline (GSK) who is involved in the study, or an immediate family member (eg, partner, offspring, parents, siblings or sibling's offspring) of an employee who is involved in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446237

Locations
United States, California
GSK Investigational Site
Fremont, California, United States, 94538
United States, Kentucky
GSK Investigational Site
Louisville, Kentucky, United States, 40217
United States, Maryland
GSK Investigational Site
Rockville, Maryland, United States, 20850
United States, New Jersey
GSK Investigational Site
Belleville, New Jersey, United States, 07109
GSK Investigational Site
Montclair, New Jersey, United States, 07042
United States, New York
GSK Investigational Site
Stony Brook, New York, United States, 11790
United States, North Carolina
GSK Investigational Site
High Point, North Carolina, United States, 27262
United States, Tennessee
GSK Investigational Site
Knoxville, Tennessee, United States, 37922
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78759
Sponsors and Collaborators
Stiefel, a GSK Company
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 115576
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 115576
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 115576
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 115576
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 115576
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 115576
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 115576
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: Stiefel, a GSK Company
ClinicalTrials.gov Identifier: NCT01446237     History of Changes
Other Study ID Numbers: 115576 
Study First Received: July 28, 2011
Last Updated: November 30, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Salicylic Acid
Benzoyl Peroxide
Salicylates
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 07, 2016