A Comparative Study of the Tolerability of Two Combination Therapies for the Treatment of Acne

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00887484
First received: April 23, 2009
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

The purpose of this study is to compare the tolerability of topical combination therapies in the treatment of facial acne.


Condition Intervention Phase
Acne Vulgaris
Drug: Clindoxyl gel
Drug: Epiduo Gel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Single-blind, Randomized, Comparative Pilot Study Evaluating the Tolerability of Two Topical Combination Therapies in the Treatment of Acne Vulgaris

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Erythema (Redness) [ Time Frame: Weeks 1 and 2 ] [ Designated as safety issue: No ]

    Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.

    Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.


  • Skin Dryness [ Time Frame: Weeks 1 and 2 ] [ Designated as safety issue: No ]

    Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.

    Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.


  • Skin Peeling [ Time Frame: Weeks 1 and 2 ] [ Designated as safety issue: No ]

    Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.

    Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3,Intense.


  • Irritant/Allergic Contact Dermatitis [ Time Frame: Weeks 1 and 2 ] [ Designated as safety issue: No ]

    Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.

    Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.



Secondary Outcome Measures:
  • Erythema (Redness) [ Time Frame: Weeks 5 and 8 ] [ Designated as safety issue: No ]

    Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.

    Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.


  • Skin Dryness [ Time Frame: Weeks 5 and 8 ] [ Designated as safety issue: No ]

    Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.

    Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.


  • Skin Peeling [ Time Frame: Weeks 5 and 8 ] [ Designated as safety issue: No ]

    Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.

    Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.


  • Irritant/Allergic Contact Dermatitis [ Time Frame: Weeks 5 and 8 ] [ Designated as safety issue: No ]

    Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.

    Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.


  • Investigators Static Global Assessment [ Time Frame: Baseline, Weeks 5, 8 ] [ Designated as safety issue: No ]
    ISGA is evaluated using the following scale: 0, Clear: Clear skin with no lesions; 1, Almost Clear: Rare non-inflammatory lesions; 2, Mild: Some non-inflammatory lesions with no more than a few inflammatory lesions but no nodular lesions); 3, Moderate: Up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 small nodular lesion; 4, Severe: Up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions; 5, Very Severe: Many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions.

  • Total Acne Lesion Counts [ Time Frame: Baseline, Weeks 5 and 8 ] [ Designated as safety issue: No ]
    Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads),

  • Inflammatory Acne Lesion Counts [ Time Frame: Baseline, Weeks 5 and 8 ] [ Designated as safety issue: No ]
    Total number of inflammatory acne lesions (pustules, papules) at each timepoint.

  • Non-inflammatory Acne Lesion Counts [ Time Frame: Baseline, Weeks 5 and 8 ] [ Designated as safety issue: No ]
    Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint.

  • Skindex-29 Quality of Life Questionnaire (QoL) - Symptomatic Domain [ Time Frame: Baseline, Weeks 2 and 8 ] [ Designated as safety issue: No ]
    Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The symptomatic score (score=0 to 28)=(sum of the 7 individual item scores) * 100/28.

  • Quality of Life Questionnaire - Emotional Domain [ Time Frame: Baseline, Weeks 2 and 8 ] [ Designated as safety issue: No ]
    Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The emotional score (score=0 to 40)=(sum of the 10 individual item scores) * 100/40.

  • Quality of Life Questionnaire - Functional Domain [ Time Frame: Baseline, Weeks 2 and 8 ] [ Designated as safety issue: No ]
    Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The functional score (score=0 to 48)=(sum of the 12 individual item scores) * 100/48.

  • Quality of Life Questionnaire - Global Score [ Time Frame: Baseline, Weeks 2 and 8 ] [ Designated as safety issue: No ]
    Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. A Global Score (range 0-100)=(sum of all 29 individual item scores) * 100/116.

  • Product Acceptability and Preference Questionnaire - Severity of Redness at Weeks 1 and 2 [ Time Frame: Weeks 1 and 2 ] [ Designated as safety issue: No ]
    Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.

  • Product Acceptability and Preference Questionnaire - Severity of Redness at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.

  • Product Acceptability and Preference Questionnaire - Severity of Dryness at Weeks 1 and 2 [ Time Frame: Weeks 1 and 2 ] [ Designated as safety issue: No ]
    Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.

  • Product Acceptability and Preference Questionnaire - Severity of Dryness at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.

  • Product Acceptability and Preference Questionnaire - Severity of Burning at Weeks 1 and 2 [ Time Frame: Weeks 1 and 2 ] [ Designated as safety issue: No ]
    Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.

  • Product Acceptability and Preference Questionnaire - Severity of Burning at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.

  • Product Acceptability and Preference Questionnaire - Severity of Itching at Weeks 1 and 2 [ Time Frame: Weeks 1 and 2 ] [ Designated as safety issue: No ]
    Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.

  • Product Acceptability and Preference Questionnaire - Severity of Itching at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.

  • Product Acceptability and Preference Questionnaire - Severity of Scaling at Weeks 1 and 2 [ Time Frame: Weeks 1 and 2 ] [ Designated as safety issue: No ]
    Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe; 5, Very Severe.

  • Product Acceptability and Preference Questionnaire - Severity of Scaling at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe; 5, Very Severe.

  • Product Acceptability and Preference Questionnaire - Ease of Application of Product at Weeks 1 and 2 [ Time Frame: Weeks 1 and 2 ] [ Designated as safety issue: No ]
    Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very easy; 2, Easy; 3, Neutral; 4, Difficult.

  • Product Acceptability and Preference Questionnaire - Ease of Application of Product at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, Very easy; 2, Easy; 3, Neutral; 4, Difficult.

  • Product Acceptability and Preference Questionnaire - Comfort of Skin at Weeks 1 and 2 [ Time Frame: Weeks 1 and 2 ] [ Designated as safety issue: No ]
    Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Comfortable; 2, Comfortable; 3, Somewhat Comfortable; 4, Somewhat Uncomfortable; 5, Uncomfortable.

  • Product Acceptability and Preference Questionnaire - Comfort of Skin at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Comfortable; 2, Comfortable; 3, Somewhat Comfortable; 4, Somewhat Uncomfortable; 5, Uncomfortable.

  • Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? at Weeks 1 and 2 [ Time Frame: Weeks 1 and 2 ] [ Designated as safety issue: No ]
    Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following choices: Epiduo, Clindoxyl Gel, Both Treatments Equally.

  • Product Acceptability and Preference Questionnaire - Comparison of Study Products Used in the Past at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, More Satisfied; 2, Somewhat More Satisfied; 3, Neither Satisfied or Dissatisfied; 4, Somewhat More Dissatisfied; 5, More Dissatisfied.

  • Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Weeks 1 and 2 [ Time Frame: Weeks 1 and 2 ] [ Designated as safety issue: No ]
    Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Highly Favorable; 2, Favorable; 3, Neutral; 4, Unfavorable; 5, Uncomfortable.

  • Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, Highly Favorable; 2, Favorable; 3, Neutral; 4, Unfavorable; 5, More Dissatisfied.

  • Product Acceptability and Preference Questionnaire - Compliance at Weeks 1 and 2 [ Time Frame: Weeks 1 and 2 ] [ Designated as safety issue: No ]
    Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Compliant at all; 1, Mostly Compliant; 2, Very Compliant.

  • Product Acceptability and Preference Questionnaire - Compliance at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Product Acceptability and Preference Questionnaire were completed by the subject at week 8 by answering Yes or No to the following question: Did you use the product every day?. When only one product was applied to the face, subjects were asked to rate their compliance by answering the aforementioned question, rather than rating compliance on a 0-2 scale.

  • Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Weeks 1 and 2 [ Time Frame: Weeks 1 and 2 ] [ Designated as safety issue: No ]
    Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product?

  • Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product?

  • Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 1 and 2 [ Time Frame: Weeks 1 and 2 ] [ Designated as safety issue: No ]
    Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: If you were to choose to continue treatment for your acne, would you use the study product?

  • Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Product Acceptability and Preference Questionnaire were completed by the subject at 8 week timepoint by answering Yes or No to the following question: If you were to choose to continue treatment for your acne, would you use the study product?

  • Product Acceptability and Preference Questionnaire - Ease of Use Wtih Make-Up at Weeks 1 and 2 [ Time Frame: Weeks 1 and 2 ] [ Designated as safety issue: No ]
    Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Applicable; 1, Very Easy; 2, Easy; 3, Neutral; 4, Difficult; 5, Very Difficult.

  • Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Applicable; 1, Very Easy; 2, Easy; 3, Neutral; 4, Difficult; 5, Very Difficult.

  • Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Weeks 1 and 2 [ Time Frame: Weeks 1 and 2 ] [ Designated as safety issue: No ]
    Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Satisfied; 2, Satisfied; 3, Neutral; 4, Unsatisfied; 5, Very Unsatisfied.

  • Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Satisfied; 2, Satisfied; 3, Neutral; 4, Unsatisfied; 5, Very Unsatisfied.


Enrollment: 48
Study Start Date: February 2009
Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clindoxyl Gel
Subject will apply both study products in a split-face fashion. Study products will be applied once-daily in the evening.
Drug: Clindoxyl gel
Commencing at baseline, subjects will apply once daily both treatment arm #1 and treatment arm #2 in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. At 2 weeks, subjects will apply clindoxyl gel to the entire face for an additional 6 weeks.
Active Comparator: Epiduo gel
Subject will apply both study products in a split-face fashion. Study products will be applied once-daily in the evening.
Drug: Epiduo Gel
Commencing at baseline, subjects will apply once daily both treatment arm #1 and treatment arm #2 in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. At 2 weeks, subjects will apply clindoxyl gel to the entire face for an additional 6 weeks.

Detailed Description:

The purpose of this study is to compare the tolerability of topical combination therapies in the treatment of facial acne.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects at least 21 years of age, in good general health with documented diagnosis of acne vulgaris.
  • Female subjects of childbearing potential must have a negative pregnancy test. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception Abstinence is considered an acceptable method of contraception.
  • Inflammatory (papules and pustules) and non-inflammatory (open and closed comedones) facial lesions.
  • The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study
  • Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed

Exclusion Criteria:

  • Female subjects who are pregnant, trying to become pregnant or breastfeeding.
  • Subjects who have any clinically relevant finding at their baseline physical other than acne vulgaris.
  • History or presence of regional enteritis or inflammatory bowel disease (eg, ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis) or similar symptoms.
  • Use of topical antibiotics or anti-acne medications on the face and systemic antibiotics within the past 2 and 4 weeks, respectively.
  • Use of topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular or intra-lesional (other than for facial acne lesions) steroids is acceptable.
  • Use of systemic retinoids within the past 6 months.
  • Facial procedures performed by an esthetician, beautician, physician, nurse, or other practitioner, within the past 4 weeks or during the conduct of the study.
  • Known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, adapalene, clindamycin, benzoyl peroxide or excipients of the study product.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00887484

Locations
Argentina
LUMIPIEL - Centro Dermatológico
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1181 ACH
Centro de Investigación y Prevencion de Enfermidades Cardiovasculares
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1119
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1181 ACH
Buenos Aires Skin
Ciudad de Buenos Aires, Buenos Aires, Argentina, C1055AAO
Sponsors and Collaborators
Stiefel, a GSK Company
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00887484     History of Changes
Other Study ID Numbers: 114544, C0000-401
Study First Received: April 23, 2009
Results First Received: September 22, 2010
Last Updated: November 6, 2012
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by GlaxoSmithKline:
Acne
Acne Vulgaris

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Benzoyl Peroxide
Clindamycin
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on April 22, 2014