Clinical TrialID 6724
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
NCT01446237
Acne Vulgaris
Relationship Network
Interactive first-hop connections across herbs, ingredients, formulas, targets, diseases, symptoms, syndromes, evidence, and monographs.
Click a node to open it in a new tab
Trial: 1Ingredient: 1Links: 1
Arranging relationship network...
Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 6724
- Evidence Id
- 6724
- Core Evidence Id
- 6724
- Source Clinical Trial Id
- 6711
- Herb2 Clinical Trial Id
- HBCT006711
- Nct Id
- NCT01446237
- Title
- 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
- Status
- Completed
- Phase
- Study Result
- Yes
- Study Condition
- Acne Vulgaris
- Study Type
- Interventional
- Study Design
- Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- OTHER: acne system - benzoyl peroxide 2.5%, Salicyclic Acid 0.5%
- Intervention Allocation
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Child, Adult
- Enrollment
- 125
- Outcome Measure
- Mean Percent Changes in Inflammatory (IL), Non-inflammatory (NIL), and Total Lesion (TL) Counts From Baseline to Each Study Visit, The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by lesion counts- IL (papules and pustules), NIL (open and closed comedones), and TL. The area considered for efficacy assessments was confined to the face. The area of the face to be examined extended from the hairline to the mandible; includes the forehead, cheeks, and chin; and excludes the mouth, nasal region, periocular area, and superior and inferior eyelids. Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value. Mean percent change from baseline at each study visit was presented., Baseline (Day 1) and Week 1, 2, 4, 8, 12|Number of Participants With a Minimum 2-grade Improvement of Investigator's Static Global Assessment (ISGA) From Baseline to Each Study Visit, The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by ISGA scale: 0- Clear (clear skin with IL or NIL), 1- Almost clear (Rare NIL with no more than rare papules), 2- Mild (greater than Grade 1, some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3- Moderate (greater than Grade 2, up to many NIL and may have some IL, but no more than one small nodular lesion), 4- Severe (greater than Grade 3, up to many NIL and IL, but no more than a few nodular lesions) and 5- Very severe (Many NIL and IL and more than a few nodular lesions. May have cystic lesions). Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value., Baseline (Day 1) and Week 1, 2, 4, 8, 12|Number of Participants With ISGA Score of 0 (Clear) or 1 (Almost Clear) at Each Study Visit, The investigator assessed efficacy at baseline (Day 1), Week 1, 2, 4, 8 and 12 by ISGA scale: 0- Clear (clear skin with IL or NIL), 1- Almost clear (Rare NIL with no more than rare papules), 2- Mild (greater than Grade 1, some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3- Moderate (greater than Grade 2, up to many NIL and may have some IL, but no more than one small nodular lesion), 4- Severe (greater than Grade 3, up to many NIL and IL, but no more than a few nodular lesions) and 5- Very severe (Many NIL and IL and more than a few nodular lesions. May have cystic lesions)., Week 1, 2, 4, 8 and 12
- Sponsor Collaborator
- Stiefel, a GSK Company|GlaxoSmithKline
- Funded By
- INDUSTRY
- Location
- GSK Investigational Site, Fremont, California, 94538, United States|GSK Investigational Site, Louisville, Kentucky, 40217, United States|GSK Investigational Site, Rockville, Maryland, 20850, United States|GSK Investigational Site, Belleville, New Jersey, 07109, United States|GSK Investigational Site, Montclair, New Jersey, 07042, United States|GSK Investigational Site, Stony Brook, New York, 11790, United States|GSK Investigational Site, High Point, North Carolina, 27262, United States|GSK Investigational Site, Knoxville, Tennessee, 37922, United States|GSK Investigational Site, Austin, Texas, 78759, United States
- Other Id
- 115576
- Start Date
- 2011-06-01
- Primary Completion Date
- 2011-12-01
- Completion Date
- 2011-12-15
- First Posted
- 2011-10-05
- Results First Posted
- 2017-04-18
- Last Update Posted
- 2017-05-25
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT01446237
- Title Cn
- Title En
- 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
- Bilingual Status
- semi_complete