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BPO

Phase 3

Acne Vulgaris | Small molecule | Dermatology |GSK plc|Last Updated: Nov 23, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment1,315
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00776919Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With AcnePHASE3 COMPLETED 1,315Oct 1, 2008Sep 1, 2009Nov 23, 201624 United States, Belize +1
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Study Endpoints
Primary Endpoints
Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12
Baseline (Day 1) and Week 12

During each study visit, investigators/assessors evaluated acne severity of the participants' faces using the ISGA scale: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L.

Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts
Baseline (Day 1) and Week 12

During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules \[small inflamed elevation of the skin that is filled with pus\], papules \[solid elevation of skin with no visible fluid\], nodules \[larger than papules with significant depth\]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin). Missing values were imputed using the last observation carried forward (LOCF) method.

Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts
Baseline (Day 1) and Week 12

During each study visit, trained study personnel at every investigational center assessed the non-inflammatory (open comedones \[blackheads\] and closed comedones \[whiteheads\]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin).

Mean Change From Baseline to Week 12 in Total Lesion Counts
Baseline (Day 1) and Week 12

During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts.

Secondary Endpoints
Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory)
Baseline (Day 1) and Week 12
Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12
Week 12
Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12
Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALclindamycin / benzoyl peroxide gel
2ACTIVE_COMPARATORClindamycin gel
3ACTIVE_COMPARATORBPO gel
4PLACEBO_COMPARATORvehicle gel
Interventions
NameTypeDescription
clindamycin / benzoyl peroxide gelDRUGOnce a day application to the face
clindamycin gelDRUGOnce a day application to the face
BPO gelDRUGOnce a day application to the face
vehicle gelDRUGOnce a day application to the face
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Eligibility Criteria
Age Range12 Years — 45 Years
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: * Be 12 to 45 years of age, inclusive, and in good general health. * Clinical diagnosis of acne vulgaris * Females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product. * H...

Countries:United StatesBelizeCanada
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