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: April 19, 2012
Last verified: April 2012
  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 Phase
Acne Vulgaris
Other: acne system - benzoyl peroxide 2.5%, Salicyclic Acid 0.5%
Phase 4

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, noninflammatory, and total lesion counts [ Time Frame: from baseline to each study visit 1, 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
  • The proportion of subjects with a minimum 2 grade improvement of Investigator's Static Global Assessment (ISGA) [ Time Frame: from baseline to each study visit 1, 2, 4, 8 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The absolute change in inflammatory, noninflammatory and total lesion count [ Time Frame: from baseline to study visits week 1, 2, 4, 8 and 12 ] [ Designated as safety issue: No ]

Enrollment: 125
Study Start Date: June 2011
Study Completion Date: February 2012
Primary Completion Date: January 2012 (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
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

No publications provided

Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT01446237     History of Changes
Other Study ID Numbers: 115576
Study First Received: July 28, 2011
Last Updated: April 19, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Benzoyl Peroxide
Salicylic Acid
Salicylates
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents
Antifungal Agents
Keratolytic 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
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 22, 2014