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Clinical Study Between Two Clindamycin 1%/Benzoyl Peroxide 5% Topical Gels

A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo Israel Pharmaceuticals, Ltd., Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel to a Comparator Clindamycin / Benzoyl Peroxide Topical Gel, and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01138514
Enrollment
1555
Registered
2010-06-07
Start date
2009-10-31
Completion date
2010-10-31
Last updated
2021-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

Brief summary

The purpose of this study is to compare the efficacy and safety profiles of Perrigo Israel Pharmaceuticals, Ltd. Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and Benzaclin® Topical Gel (Clindamycin- Benzoyl Peroxide Gel).

Interventions

DRUGClindamycin 1% / Benzoyl Peroxide 5% (Perrigo)

Applied to the entire face twice daily for 10 weeks

DRUGClindamycin 1% / Benzoyl Peroxide 5% (Benzaclin)

Applied to the entire face twice daily for 10 weeks

DRUGPlacebo

Placebo

Sponsors

Padagis LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Healthy men or women, 12 to 65 years of age * Willing to participate and sign provide written consent * Moderate to severe acne

Exclusion criteria

* Pregnant or lactating women * History of unresponsiveness or hypersensitivity to clindamycin, benzoyl peroxide or lincomycin * Use of systemic, topical or facial products which may interfere with the study * Participation in any clinical study in the 30 days prior to study entry * Prolonged exposure to sunlight or excessive exposure to UV lights * Chronic use of NSAIDS

Design outcomes

Primary

MeasureTime frame
Percent Change From Baseline in Inflammatory Lesions10 weeks
Percent Change From Baseline in Non-inflammatory Lesions10 weeks

Secondary

MeasureTime frameDescription
Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA)10 weeksClinical success was defined as a score of clear (0) or almost clear (1) at Week 10.

Participant flow

Participants by arm

ArmCount
Clindamycin 1%/Benzoyl Peroxide 5%
Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
522
Reference Product
Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
516
Vehicle
Placebo: Placebo
517
Total1,555

Baseline characteristics

CharacteristicClindamycin 1%/Benzoyl Peroxide 5%Reference ProductVehicleTotal
Age, Continuous20.2 years
STANDARD_DEVIATION 7.6
20.1 years
STANDARD_DEVIATION 7.4
20.7 years
STANDARD_DEVIATION 8.1
20.4 years
STANDARD_DEVIATION 7.7
Ethnicity (NIH/OMB)
Hispanic or Latino
253 Participants268 Participants251 Participants772 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
269 Participants248 Participants266 Participants783 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants1 Participants3 Participants6 Participants
Race (NIH/OMB)
Asian
11 Participants10 Participants10 Participants31 Participants
Race (NIH/OMB)
Black or African American
90 Participants80 Participants98 Participants268 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants1 Participants1 Participants3 Participants
Race (NIH/OMB)
Unknown or Not Reported
110 Participants114 Participants109 Participants333 Participants
Race (NIH/OMB)
White
308 Participants310 Participants296 Participants914 Participants
Sex: Female, Male
Female
284 Participants282 Participants279 Participants845 Participants
Sex: Female, Male
Male
238 Participants234 Participants238 Participants710 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
49 / 52249 / 51672 / 517
serious
Total, serious adverse events
0 / 5220 / 5160 / 517

Outcome results

Primary

Percent Change From Baseline in Inflammatory Lesions

Time frame: 10 weeks

Population: Per protocol population

ArmMeasureValue (MEAN)Dispersion
Clindamycin 1%/Benzoyl Peroxide 5%Percent Change From Baseline in Inflammatory Lesions79.87 percentage of lesion reductionStandard Deviation 27.38
Reference ProductPercent Change From Baseline in Inflammatory Lesions80.86 percentage of lesion reductionStandard Deviation 24.65
VehiclePercent Change From Baseline in Inflammatory Lesions45.60 percentage of lesion reductionStandard Deviation 44.01
p-value: 0.0590% CI: [95.2, 102.5]Fieller's method
Primary

Percent Change From Baseline in Non-inflammatory Lesions

Time frame: 10 weeks

Population: Per protocol population

ArmMeasureValue (MEAN)Dispersion
Clindamycin 1%/Benzoyl Peroxide 5%Percent Change From Baseline in Non-inflammatory Lesions70.21 percentage of lesion reductionStandard Deviation 30.48
Reference ProductPercent Change From Baseline in Non-inflammatory Lesions70.02 percentage of lesion reductionStandard Deviation 28.77
VehiclePercent Change From Baseline in Non-inflammatory Lesions36.16 percentage of lesion reductionStandard Deviation 48.15
p-value: 0.0590% CI: [95.6, 105.2]Fieller's method
Secondary

Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA)

Clinical success was defined as a score of clear (0) or almost clear (1) at Week 10.

Time frame: 10 weeks

Population: per-protocol population

ArmMeasureValue (NUMBER)
Clindamycin 1%/Benzoyl Peroxide 5%Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA)247 participants
Reference ProductNumber of Participant With Clinical Success on the Investigator's Global Assessment (IGA)234 participants
VehicleNumber of Participant With Clinical Success on the Investigator's Global Assessment (IGA)79 participants
p-value: 0.0590% CI: [-4.2, 7.4]Wald's method Yates' continuity correct

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026