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

A Single-blind, Randomized, Comparative Pilot Study Evaluating the Tolerability of Two Topical Combination Therapies in the Treatment of Acne Vulgaris

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

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: BENZOYL PEROXIDE/ CLINDAMYCIN; Drug: BENZOYL PEROXIDE/ ADAPALENE

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1119
      • Centro de Investigación y Prevencion de Enfermidades Cardiovasculares
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1181 ACH
      • Hospital Italiano de Buenos Aires
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1181 ACH
      • LUMIPIEL - Centro Dermatológico
    • Ciudad de Buenos Aires, Buenos Aires, Argentina, C1055AAO
      • Buenos Aires Skin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: BENZOYL PEROXIDE/ CLINDAMYCIN; 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 benzoyl peroxide/clindamycin 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: BENZOYL PEROXIDE/ ADAPALENE; 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 benzoyl peroxide/clindamycin gel to the entire face for an additional 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Erythema (Redness)	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.	Weeks 1 and 2
Skin Dryness	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.	Weeks 1 and 2
Skin Peeling	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.	Weeks 1 and 2
Irritant/Allergic Contact Dermatitis	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.	Weeks 1 and 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Erythema (Redness)	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.	Weeks 5 and 8
Skin Dryness	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.	Weeks 5 and 8
Skin Peeling	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.	Weeks 5 and 8
Irritant/Allergic Contact Dermatitis	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.	Weeks 5 and 8
Investigators Static Global Assessment	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.	Baseline, Weeks 5, 8
Total Acne Lesion Counts	Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads),	Baseline, Weeks 5 and 8
Inflammatory Acne Lesion Counts	Total number of inflammatory acne lesions (pustules, papules) at each timepoint.	Baseline, Weeks 5 and 8
Non-inflammatory Acne Lesion Counts	Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint.	Baseline, Weeks 5 and 8
Skindex-29 Quality of Life Questionnaire (QoL) - Symptomatic Domain	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.	Baseline, Weeks 2 and 8
Quality of Life Questionnaire - Emotional Domain	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.	Baseline, Weeks 2 and 8
Quality of Life Questionnaire - Functional Domain	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.	Baseline, Weeks 2 and 8
Quality of Life Questionnaire - Global Score	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.	Baseline, Weeks 2 and 8
Product Acceptability and Preference Questionnaire - Severity of Redness at Weeks 1 and 2	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.	Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Severity of Redness at Week 8	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.	Week 8
Product Acceptability and Preference Questionnaire - Severity of Dryness at Weeks 1 and 2	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.	Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Severity of Dryness at Week 8	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.	Week 8
Product Acceptability and Preference Questionnaire - Severity of Burning at Weeks 1 and 2	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.	Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Severity of Burning at Week 8	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.	Week 8
Product Acceptability and Preference Questionnaire - Severity of Itching at Weeks 1 and 2	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.	Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Severity of Itching at Week 8	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.	Week 8
Product Acceptability and Preference Questionnaire - Severity of Scaling at Weeks 1 and 2	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.	Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Severity of Scaling at Week 8	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.	Week 8
Product Acceptability and Preference Questionnaire - Ease of Application of Product at Weeks 1 and 2	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.	Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Ease of Application of Product at Week 8	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.	Week 8
Product Acceptability and Preference Questionnaire - Comfort of Skin at Weeks 1 and 2	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.	Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Comfort of Skin at Week 8	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.	Week 8
Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? at Weeks 1 and 2	Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following choices: Epiduo, Clindoxyl Gel, Both Treatments Equally.	Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Comparison of Study Products Used in the Past at Week 8	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.	Week 8
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Weeks 1 and 2	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.	Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Week 8	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.	Week 8
Product Acceptability and Preference Questionnaire - Compliance at Weeks 1 and 2	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.	Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Compliance at Week 8	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.	Week 8
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Weeks 1 and 2	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?	Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Week 8	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?	Week 8
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 1 and 2	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?	Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 8	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?	Week 8
Product Acceptability and Preference Questionnaire - Ease of Use Wtih Make-Up at Weeks 1 and 2	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.	Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up at Week 8	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.	Week 8
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Weeks 1 and 2	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.	Weeks 1 and 2
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Week 8	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.	Week 8

Collaborators and Investigators

• Sponsor: Stiefel, a GSK Company
• Collaborators: GlaxoSmithKline

Publications and helpful links

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: April 23, 2009
• First Submitted That Met QC Criteria: April 23, 2009
• First Posted (Estimate): April 24, 2009

Study Record Updates

• Last Update Posted (Estimate): December 13, 2016
• Last Update Submitted That Met QC Criteria: October 28, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Acne; Acne Vulgaris
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide; Adapalene
• Other Study ID Numbers: 114544

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Clinical Study Report
   Information identifier: 114544
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Informed Consent Form
   Information identifier: 114544
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Individual Participant Data Set
   Information identifier: 114544
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Dataset Specification
   Information identifier: 114544
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Study Protocol
   Information identifier: 114544
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register