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clindamycin1%/tretinoin 0.025%

Phase 3

Acne Vulgaris | Small molecule | Dermatology |GSK plc|Last Updated: Jul 18, 2017

Target and mechanism

ModalitySmall molecule

Also known as Clindamycin gel, Clindamycin, Clindamycin Gel (clindamycin )

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials3
Total Enrollment3,028

FDA Designations

No designations recorded

Clinical trial landscape

clindamycin1%/tretinoin 0.025% · 3 trials · 2 indications

Phase 3 2Phase 1 1
NCT00776919Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With AcneAcne Vulgaris
COMPLETED1,315 Analytics
NCT00689117A Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called CT GelAcne Vulgaris
COMPLETED1,649 Analytics
PHASE3COMPLETED
Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne
Acne VulgarisUnlock trial analytics
PHASE3COMPLETED
A Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called CT Gel
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.

Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study)
Baseline, Week 12

Acne lesion counts (inflammatory \[papules, pustules, nodules\], non-inflammatory \[open and closed comedones\], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts.

The Percentage of Participants Who Had a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12
Baseline, Week 12

The ISGA is a static ("snap-shot") evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. Change is calculated as the Week 12 value minus the Baseline value.

The primary endpoint will be inflammatory response or superficial effect at challenge period. Inflammatory responses (erythema and local skin reactions) or superficial effects (if observed) will be scored according to the grading scales.
Day 44 - 65

In cases where the patch area is larger than the irradiated area, only the irradiated areas will be scored unless reactions outside the irradiated area exhibit unusual responses. Scores represent the presence of clinically significant effects on at least 25% of the test site. Questionable, barely perceptible, or minimal reactions involving less than 25% of the test site will not be considered significant.

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
occlusive patch 200 uL of clindamycin1%/tretinoin0.025% GelEXPERIMENTALocclusive patch 200 uL of clindamycin1%/tretinoin0.025% Gel
occlusive patch 200uL of vehicle gelPLACEBO_COMPARATORocclusive patch 200uL of vehicle 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
CT GelDRUGTopical gel consisting of clindamycin 1% and tretinoin 0.025%, applied once daily in the evening for 12 weeks
Clindamycin Gel (clindamycin )DRUGClindamycin 1% gel applied topically once daily in the evening for 12 weeks
Tretinoin Gel (tretinoin)DRUGTretinoin 0.025% gel applied topically once daily in the evening for 12 weeks
clindamycin1%/tretinoin 0.025% gelDRUGclindamycin1%/tretinoin 0.025% gel
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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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