NCT00837213

Brief Summary

To compare the efficacy and safety of Benzoyl peroxide used in combination with clindamycin vs. Benzoyl peroxide used in combination with clindamycin and doxycycline in the treatment of moderate acne

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2009

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

August 31, 2010

Completed
Last Updated

May 25, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

February 4, 2009

Results QC Date

April 7, 2010

Last Update Submit

May 24, 2017

Conditions

Acne

Keywords

Acne

Outcome Measures

Primary Outcomes (4)

  • Percent Change in Inflammatory Acne Lesions From Baseline to Week 16

    Percent change from baseline to week 16 in inflammatory acne lesions (pustules/papules)(chest and back)

    Baseline, Week 16

  • Percent (%) Change in Non-inflammatory Acne Lesions From Baseline to Week 16.

    Percent change in Non-inflammatory acne lesions (whiteheads and blackheads)(chest and back) from baseline to week 16.

    Baseline, Week 16

  • Percent Change in Total Acne Lesion Counts From Baseline to Week 16

    Percent change from baseline to week 16 in total acne lesions (inflammatory + non-inflammatory)

    Baseline, Week 16

  • Change in Investigator Global Assessment (IGA)

    Change in Investigator Global Assessment (IGA) Average values chest and back. IGA scale: 0 - Clear 0.5 - Clear/almost clear 1. Almost Clear 1.5- Almost Clear/Mild 2. Mild 2.5- Mild/Moderate 3. Moderate 3.5- Moderate/Severe

    Baseline, Weeks 4, 8,12, and 16

Secondary Outcomes (4)

  • Percent (%) Change in Inflammatory Lesion Counts (Chest and Back) From Baseline to Week 12

    Baseline, Week 12

  • Percent Change in Non-inflammatory Lesions (Chest and Back) From Baseline to Week 12

    Baseline, Week 12

  • Percent Change in Total Lesions (Chest and Back) From Baseline to Week 12

    Week 12

  • Percentage of Particpants With IGA Score at Week 16

    Baseline, Week 16

Study Arms (2)

BPO with clindamycin foam

ACTIVE COMPARATOR

Benzoyl peroxide (BPO) wash with clindamycin foam

Drug: Benzoyl peroxide with clindamycin

BPO + clindamycin foam + doxycycline

ACTIVE COMPARATOR

Benzoyl peroxide (BPO) wash with clindamycin foam and doxycycline capsules

Drug: Benzoyl peroxide with clindamycin and doxycycline

Interventions

Benzoyl peroxide with clindamycinDRUG

Benzoyl peroxide wash - Clindamycin foam

Also known as: Acne
BPO with clindamycin foam
Benzoyl peroxide with clindamycin and doxycyclineDRUG

Benzoyl peroxide wash - Clindamycin foam - Doxycycline capsules

Also known as: Acne
BPO + clindamycin foam + doxycycline

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects with acne vulgaris . Able to understand the requirements of the study and sign informed consent/HIPAA authorization forms.

You may not qualify if:

  • Known hypersensitivity to any of the components of the study drugs or used of prohibited medications or any medical condition that contraindicate the subject's participation in the clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center for Dermatology, Cosmetic and Laser Surgery

Fremont, California, 94538, United States

Location

Las Vegas Skin & Cancer Clinic

Las Vegas, Nevada, 89129, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Benzoyl PeroxideClindamycinAcne RA-1,2Doxycycline

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

BenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsLincomycinLincosamidesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlycosidesCarbohydratesTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Limitations and Caveats

Small sample size did not provide adequate power. Even with the limited sample size, total lesion counts provides a more reliable view of the study data due to the greater number of lesions to work with.

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2009

First Posted

February 5, 2009

Study Start

August 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

May 25, 2017

Results First Posted

August 31, 2010

Record last verified: 2017-05

Locations

US(2)