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BPO

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment1,315

FDA Designations

No designations recorded

Clinical trial landscape

BPO · 1 trial · 1 indication

Phase 3 1
NCT00776919Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With AcneAcne Vulgaris
COMPLETED1,315 Analytics
PHASE3COMPLETED
Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne
Acne VulgarisUnlock trial analytics

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 to 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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Frequently asked questions about BPO

What is BPO used for?

BPO is a small molecule drug being developed for the treatment of acne vulgaris, a common skin condition characterized by pimples and inflammation. It is currently in Phase 3 clinical development and is being studied in a randomized, double-blind, placebo-controlled trial.

What does BPO target?

BPO is a small molecule drug that targets acne vulgaris. It is being evaluated in a Phase 3 clinical trial for its efficacy and safety in treating this condition. The trial is biomarker-selected, meaning participants are chosen based on specific biological markers.

Who makes BPO?

BPO is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The drug is currently in Phase 3 clinical development for the treatment of acne vulgaris.

What phase is BPO in?

BPO is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for the treatment of acne vulgaris in a completed Phase 3 trial.

What clinical trials is BPO in?

BPO has been studied in one Phase 3 clinical trial with the identifier NCT00776919, titled "Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne." This trial enrolled 1,315 participants with acne vulgaris and was conducted in the United States, Belize, and Canada.

Is BPO the same as benzoyl peroxide?

BPO is a drug being developed by GSK plc for the treatment of acne vulgaris. It is currently in Phase 3 clinical development and has been studied in a placebo-controlled trial. The drug is being evaluated for its efficacy and safety in treating this condition.