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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00887484
• Other study ID #: 114544
• Secondary ID: C0000-401
• Status: Completed
• Phase: Phase 4
• First received: April 23, 2009
• Last updated: November 6, 2012
• Start date: February 2009
• Est. completion date: July 2009

Study information

• Verified date: November 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

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.
• 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.

Locations

Country	Name	City	State
Argentina	Centro de Investigación y Prevencion de Enfermidades Cardiovasculares	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Hospital Italiano de Buenos Aires	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	LUMIPIEL - Centro Dermatológico	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Buenos Aires Skin	Ciudad de Buenos Aires	Buenos Aires

Sponsors (2)

Lead Sponsor	Collaborator
Stiefel, a GSK Company	GlaxoSmithKline

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Inflammatory Acne Lesion Counts	Total number of inflammatory acne lesions (pustules, papules) at each timepoint.	Baseline, Weeks 5 and 8	No
Secondary	Non-inflammatory Acne Lesion Counts	Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint.	Baseline, Weeks 5 and 8	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No