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Completed

NCT Number: NCT00891982

A Clinical Study to Evaluate the Tolerability of a Topical Antibiotic and Retinoid Used in a Combined Regimen With a BPO Wash

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dermatology Associates Research, Coral Gables, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

CTGel/ BPO Wash

Drug

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.

Other names: Veltin

Soap Free Cleanser and CTGel

Drug

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.

Other names: Veltin

Primary outcomes

  1. Local Tolerability - Skin Dryness

    Time frame: Screening/baseline

    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

    • - Trace
    • - Mild
    • - Moderate
    • - Marked
    • - Severe

  2. Local Tolerability - Skin Dryness

    Time frame: Week 1

    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

    • - Trace
    • - Mild
    • - Moderate
    • - Marked
    • - Severe

  3. Local Tolerability - Skin Dryness

    Time frame: Week 2

    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

    • - Trace
    • - Mild
    • - Moderate
    • - Marked
    • - Severe

  4. Local Tolerability - Skin Dryness

    Time frame: Week 4

    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

    • - Trace
    • - Mild
    • - Moderate
    • - Marked
    • - Severe

  5. Local Tolerability - Skin Scaling

    Time frame: Screening/baseline

    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

    • - Trace
    • - Mild
    • - Moderate
    • - Marked
    • - Severe

  6. Local Tolerability - Skin Scaling

    Time frame: Week 1

    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

    • - Trace
    • - Mild
    • - Moderate
    • - Marked
    • - Severe

  7. Local Tolerability - Skin Scaling

    Time frame: Week 2

    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

    • - Trace
    • - Mild
    • - Moderate
    • - Marked
    • - Severe

  8. Local Tolerability - Skin Scaling

    Time frame: Week 4

    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

    • - Trace
    • - Mild
    • - Moderate
    • - Marked
    • - Severe

  9. Local Tolerability - Erythema (Redness)

    Time frame: Screening/baseline

    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

    • - Trace
    • - Mild
    • - Moderate
    • - Marked
    • - Severe

  10. Local Tolerability - Erythema (Redness)

    Time frame: Week 1

    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

    • - Trace
    • - Mild
    • - Moderate
    • - Marked
    • - Severe

  11. Local Tolerability - Erythema (Redness)

    Time frame: Week 2

    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

    • - Trace
    • - Mild
    • - Moderate
    • - Marked
    • - Severe

  12. Local Tolerability - Erythema (Redness)

    Time frame: Week 4

    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

    • - Trace
    • - Mild
    • - Moderate
    • - Marked
    • - Severe

Secondary outcomes

  1. Subject Assessment of Burning/Stinging

    Time frame: Screening/baseline

    Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:

    0 - None

    • - Trace
    • - Mild
    • - Moderate
    • - Marked
    • - Severe

  2. Subject Assessment of Burning/Stinging

    Time frame: Week 1

    Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:

    0 - None

    • - Trace
    • - Mild
    • - Moderate
    • - Marked
    • - Severe

  3. Subject Assessment of Burning/Stinging

    Time frame: Week 2

    Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:

    0 - None

    • - Trace
    • - Mild
    • - Moderate
    • - Marked
    • - Severe

  4. Subject Assessment of Burning/Stinging

    Time frame: Week 4

    Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:

    0 - None

    • - Trace
    • - Mild
    • - Moderate
    • - Marked
    • - Severe

  5. Subject Assessment of Itching

    Time frame: Screening/Baseline

    Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:

    0 - None

    • - Trace
    • - Mild
    • - Moderate
    • - Marked
    • - Severe

  6. Subject Assessment of Itching

    Time frame: Week 1

    Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:

    0 - None

    • - Trace
    • - Mild
    • - Moderate
    • - Marked
    • - Severe

  7. Subject Assessment of Itching

    Time frame: Week 2

    Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:

    0 - None

    • - Trace
    • - Mild
    • - Moderate
    • - Marked
    • - Severe

  8. Subject Assessment of Itching

    Time frame: Week 4

    Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:

    0 - None

    • - Trace
    • - Mild
    • - Moderate
    • - Marked
    • - Severe

Sponsors and collaborators

Lead sponsor

Stiefel, a GSK Company

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

A Phase 3B, Multicenter, Assessor-Blinded Study of the Tolerability of Clindamycin 1%-Tretinoin 0.025% Gel Used in Conjunction With Benzoyl Peroxide 4% Wash in Subjects With Mild to Moderate Facial Acne Vulgaris

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 1, 2009
Registry last updated
May 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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