NCT00891982

Brief Summary

The purpose of this study is to evaluate the tolerability of a combined regimen of a topical antibiotic and retinoid and a benzoyl peroxide wash.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

5 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

April 1, 2009

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2009

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

July 25, 2011

Completed
Last Updated

May 24, 2017

Status Verified

May 1, 2017

Enrollment Period

2 months

First QC Date

April 29, 2009

Results QC Date

October 6, 2010

Last Update Submit

May 19, 2017

Conditions

Acne Vulgaris

Keywords

Acne Vulgaris

Outcome Measures

Primary Outcomes (12)

  • Local Tolerability - Skin Dryness

    Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe

    Screening/baseline

  • Local Tolerability - Skin Dryness

    Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe

    Week 1

  • Local Tolerability - Skin Dryness

    Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe

    Week 2

  • Local Tolerability - Skin Dryness

    Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe

    Week 4

  • Local Tolerability - Skin Scaling

    Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe

    Screening/baseline

  • Local Tolerability - Skin Scaling

    Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe

    Week 1

  • Local Tolerability - Skin Scaling

    Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe

    Week 2

  • Local Tolerability - Skin Scaling

    Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe

    Week 4

  • Local Tolerability - Erythema (Redness)

    Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe

    Screening/baseline

  • Local Tolerability - Erythema (Redness)

    Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe

    Week 1

  • Local Tolerability - Erythema (Redness)

    Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe

    Week 2

  • Local Tolerability - Erythema (Redness)

    Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe

    Week 4

Secondary Outcomes (8)

  • Subject Assessment of Burning/Stinging

    Screening/baseline

  • Subject Assessment of Burning/Stinging

    Week 1

  • Subject Assessment of Burning/Stinging

    Week 2

  • Subject Assessment of Burning/Stinging

    Week 4

  • Subject Assessment of Itching

    Screening/Baseline

  • +3 more secondary outcomes

Study Arms (2)

CTGel plus BPO wash

EXPERIMENTAL

Benzoyl peroxide (BPO) Wash in the morning and CTGel in the evening

Drug: CTGel/ BPO Wash

CTGel

ACTIVE COMPARATOR

Soap Free Cleanser in the morning and CTGel in the evening

Drug: Soap Free Cleanser and CTGel

Interventions

CTGel/ BPO WashDRUG

Benzoyl Peroxide (BPO) wash will be used once daily in the morning for 28 days Clindamycin and Tretinoin (CT) gel will be used once daily in the evening for 28 days.

Also known as: Veltin
CTGel plus BPO wash
Soap Free Cleanser and CTGelDRUG

Soap Free Cleanser will be used once daily in the morning for 28 days Clindamycin and Tretinoin gel will be used once daily in the evening for 28 days.

Also known as: Veltin
CTGel

Eligibility Criteria

Age12 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Subjects with mild to moderate facial acne vulgaris, with no history of known or suspected hypersensitivity or previous allergic reaction to any of the ingredients of the study products (eg, topical antibiotics, retinoids or benzoyl peroxide), capable of understanding and willing to provide signed and dated written voluntary informed consent and able to complete the study and to comply with study instructions.
  • Female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study.

You may not qualify if:

  • Use of topical antibiotics on the face within the past 2 weeks or use of systemic antibiotics within the past 4 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Dermatology Associates Research

Coral Gables, Florida, 33134, United States

Location

Grekin Skin Institute

Warren, Michigan, 48088, United States

Location

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

Location

The Skin Wellness Center, PC

Knoxville, Tennessee, 37922, United States

Location

Premier Clinical Research

Spokane, Washington, 99204, United States

Location

Related Publications (1)

  • Draelos ZD, Potts A, Alio Saenz AB; W0265-306 Study Group. Randomized tolerability analysis of clindamycin phosphate 1.2%-tretinoin 0.025% gel used with benzoyl peroxide wash 4% for acne vulgaris. Cutis. 2010 Dec;86(6):310-8.

    PMID: 21284283BACKGROUND

MeSH Terms

Conditions

Acne Vulgaris

Interventions

clindamycin, tretinoin drug combination

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

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
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2009

First Posted

May 1, 2009

Study Start

April 1, 2009

Primary Completion

June 1, 2009

Study Completion

June 5, 2009

Last Updated

May 24, 2017

Results First Posted

July 25, 2011

Record last verified: 2017-05

Locations

US(5)