Recent Updates
Recently added Catalysts

Benzoyl peroxide

Phase 2

Acne Vulgaris | Small molecule | Dermatology |GSK plc|Last Updated: Mar 6, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment591
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00713609Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With AcnePHASE2 COMPLETED 591Jun 1, 2008Mar 1, 2009Mar 6, 201716 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12
Baseline and up to Week 12

The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts \[only post-Baseline\]) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles).

Proportion of Participants With a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12
Baseline and up to Week 12

An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed.

Secondary Endpoints
Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory)
Baseline and up to Week 12
Proportion of Participants With an ISGA Score of 0 or 1 at Week 12
Week 12
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALBenzoyl peroxide/clindamycin gel + tazarotene cream
2ACTIVE_COMPARATORBenzoyl peroxide/clindamycin gel + vehicle cream
3ACTIVE_COMPARATORBenzoyl peroxide gel + tazarotene cream
4ACTIVE_COMPARATORClindamycin gel + tazarotene cream
5ACTIVE_COMPARATORVehicle gel+ tazarotene cream
6PLACEBO_COMPARATORVehicle gel + vehicle cream
Interventions
NameTypeDescription
Benzoyl peroxide gelDRUG5% benzoyl peroxide in a gel applied topically once a day
Clindamycin gelDRUG1% clindamycin phosphate applied topically once a day
Tazarotene creamDRUG0.1 % tazarotene in a cream applied topically once a day
Vehicle gelDRUGVehicle gel is an identical gel without the active ingredients
Vehicle creamDRUGVehicle cream is an identical cream without the active ingredients
Unlock Study Design Details
Eligibility Criteria
Age Range12 Years — 45 Years
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * Inclusion Criteria: Subjects must be males or females 12 to 45 years of age. * Subjects must have acne on their face. * Female subjects of childbearing potential must have a negative pregnancy test. If sexually active, one medically acceptable forms of contraception must be pr...

Countries:United States
Unlock Eligibility Criteria