- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02058628
Comparison of the Efficacy and Safety of Clindamycin + Benzoyl Peroxide Formulation With Azelaic Acid Formulation in the Treatment of Acne Vulgaris
August 24, 2017 updated by: GlaxoSmithKline
A Multi-centre, Single-blind, Parallel Group, Clinical Evaluation of the Efficacy and Safety of Clindamycin 1% / Benzoyl Peroxide 3% and Azelaic Acid 20% in the Topical Treatment of Mild to Moderate Acne Vulgaris
This is a randomized, comparator-controlled, single-blind, parallel-group study.
The current study proposes to compare a fixed-dose combination product containing 3% benzoyl peroxide (BPO) and 1% clindamycin against a cream containing 20% azelaic acid for the treatment of facial acne vulgaris.
The results of the study will enable a better assessment of the safety and efficacy of the new dose regime (BPO 3% + clindamycin 1%) in comparison to a well established treatment.
Based on the data more evidence based recommendations will be possible to improve the treatment of subjects with acne vulgaris.
A total of 220 subjects will be enrolled and will have 5 study visits (Day 1, Weeks 2, 4, 8 and 12).
The duration of the study will be over 12 weeks.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
222
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berlin, Germany, 10783
- GSK Investigational Site
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Baden-Wuerttemberg
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Stuttgart, Baden-Wuerttemberg, Germany, 70178
- GSK Investigational Site
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Tuebingen, Baden-Wuerttemberg, Germany, 72076
- GSK Investigational Site
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Bayern
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Augsburg, Bayern, Germany, 86179
- GSK Investigational Site
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Gilching, Bayern, Germany, 82205
- GSK Investigational Site
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Brandenburg
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Mahlow, Brandenburg, Germany, 15831
- GSK Investigational Site
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Niedersachsen
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Duelmen, Niedersachsen, Germany, 48249
- GSK Investigational Site
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Nordrhein-Westfalen
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Duesseldorf, Nordrhein-Westfalen, Germany, 40212
- GSK Investigational Site
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Sachsen-Anhalt
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Dessau, Sachsen-Anhalt, Germany, 06847
- GSK Investigational Site
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Magdeburg, Sachsen-Anhalt, Germany, 39120
- GSK Investigational Site
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Schleswig-Holstein
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Kiel, Schleswig-Holstein, Germany, 24148
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 45 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects who are males or females 12 to 45 years of age, inclusive.
- Subjects with acne vulgaris who have: a minimum of 17 to a maximum of 60 inflammatory facial lesions (papules and pustules), including the nose, and no more than 1 facial nodular cystic lesions and a minimum of 20 to a maximum of 125 non-inflammatory facial lesions (open and closed comedones) and an ISGA score of 2 or 3.
- Subjects agreeing not to use sun-beds or undergo any ultraviolet (UV) light treatment for 4 weeks prior to entering the study and to minimize the amount of exposure to direct sunlight for the duration of the study.
- Subjects who are capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol-specific procedures are performed. Subjects under the legal age of consent must provide assent and have the written, informed consent of both parents or legal guardians.
Exclusion Criteria:
- Unable to comply with the requirement of the study.
- Female subjects who are pregnant, breast-feeding, or sexually active and not using reliable contraception and/or not prepared to do so for the duration of the trial (a negative pregnancy test must be confirmed at Visit 1, 3, 4 and 5, for all females if menarche has occurred).
- Subjects who have any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases or diseases of the facial skin other than acne vulgaris.
- Subjects who have facial hair that may obscure the accurate assessment of acne grade.
- Subjects who have a 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.
- Prior Therapy: Have received treatment with the following therapies at the times specified prior to Baseline: systemic retinoids [6 months]; systemic antibiotics, investigational therapy, facial procedure (chemical or laser peel, microdermabrasion, artificial UV therapy), topical corticosteroids on the face or systemic corticosteroids [4 weeks]; topical antibiotics on the face, topical anti-acne medications (eg, BPO, retinoids, azelaic acid, resorcinol, salicylates, sulfacetamide sodium and derivatives, glycolic acid) [2 weeks]; medications that are reported to exacerbate acne (eg, mega-doses of certain vitamins such as vitamin D, vitamin A, and vitamins B2, B6, and B12; haloperidol; halogens such as iodide and bromide; lithium; hydantoin; and phenobarbital) as these may impact efficacy assessments, neuromuscular blocking agents (Clindamycin has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents), drugs known to be photosensitizers (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of increased phototoxicity [1 day].
- Subjects who are unwilling to stop using the following types of facial products during the study: astringents, toners, abradants, facials, peels containing glycolic or other acids, masks, washes or soaps containing BPO, sulfacetamide sodium or salicylic acid, non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid, or alpha- or beta-hydroxy acids.
- Subjects who have a known hypersensitivity or previous allergic reaction to any of the active components (azaleic acid, lincomycin, clindamycin, BPO), or excipients of the study medication.
- Use of estrogens, including oral, implanted, and topical contraceptives, androgens, or anti-androgenic agents of less than 12 consecutive weeks prior to start of study dosing (change of the dose or drug is not permitted between 12 weeks prior study dosing until end of the study).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Arm 1
A total of 110 subjects will receive clindamycin + BPO once daily in the evening for 12 weeks as per the randomization schedule.
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Gel containing 1.2% clindamycin and 3% BPO for once daily application
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Experimental: Arm 2
A total of 110 subjects will receive azelaic acid twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization schedule.
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Cream containing 20% azelaic acid for twice daily application
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage Change From Baseline (Day 1) of Inflammatory Lesion (IL) Count at Week 4 - Superiority Analysis
Time Frame: Baseline (Day 1) and Week 4
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A count of IL (papules and pustules, including nasal lesions) was performed at baseline and up to Week 12. Lesion counts were confined to the face.
Baseline was defined at Visit 1 (Day 1).
Change from Baseline in the number of IL was defined as Week 4 values minus the Baseline values.
Raw data has been presented for outcome measure results; however, p value is derived from the Wilcoxon test mean scores.
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Baseline (Day 1) and Week 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Absolute Change From Baseline in IL, Non-inflammatory Lesions (NIL) and Calculated Total Lesions to Weeks 2, 4, 8 and 12
Time Frame: Baseline (Day 1) up to Week 2, 4, 8, 12
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A count of IL (papules and pustules, including nasal lesions), NIL (open and closed comedones) and total lesions was performed at baseline and up to Week 12. Lesion counts were confined to the face.
Baseline was defined at Visit 1 (Day 1).
Change from Baseline in the number of IL was defined as week 12 values minus the Baseline values.
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Baseline (Day 1) up to Week 2, 4, 8, 12
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Percentage Change From Baseline in IL, NIL and Calculated Total Lesions at Weeks 2, 4, 8 and 12
Time Frame: Baseline (Day 1) up to Week 2, 4, 8, 12
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A count of IL (papules and pustules, including nasal lesions),NIL (open and closed comedones) and total lesions was performed at baseline and up to Week 12. Lesion counts were confined to the face.
Baseline was defined at Visit 1 (Day 1).
Change from Baseline in the number of IL was defined as week 12 values minus the Baseline values.
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Baseline (Day 1) up to Week 2, 4, 8, 12
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Speed of Onset : Time to 50 Percent Reduction in Total Lesion Count
Time Frame: Week 12
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The average time to 50 percent reduction of the calculated total lesion count was analyzed by determination of the number of days between Baseline and the first visit with a 50 percent reduction of the count.
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Week 12
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Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
Time Frame: Baseline (Day 1) up to Weeks 2, 4, 8, 12
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ISGA was conducted at all study visits.
The area considered for the ISGA was confined to the face.
A 0-5 point rating scale was used: 0 means Clear- Clear skin with no IL or NIL, 1 means Almost Clear- Rare NIL with no more than one small IL, 2 means Mild- Some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3 means Moderate- Up to many NIL and may have some IL, but no more than one small nodular lesion, 4 means Severe- Up to many NIL and IL, but no more than a few nodular lesions and 5 means Very Severe- Many NIL and IL and more than a few nodular lesions, may have cystic lesions.
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Baseline (Day 1) up to Weeks 2, 4, 8, 12
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Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
Time Frame: Baseline (Day 1) and Weeks 2, 4, 8, 12
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Tolerability was assessed by investigator on a 0-3 point rating scale for erythema (0- None, 1- Slight, 2- Some and 3- Very red), dryness (0- None, 1- Slight, 2- Some and 3- Very dry) and peeling (0- None, 1- Slight, 2- Moderate and 3- Strong).
A shift table was provided to deduce how the results are varying from the baseline visit to post-baseline visits.
Change from Baseline is the value at indicated time point minus the Baseline value.
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Baseline (Day 1) and Weeks 2, 4, 8, 12
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Number of Participants With Participant Global Change Assessment Score 12 Weeks
Time Frame: Weeks 2, 4, 8 and 12
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An SGCA was conducted by the participant to assess the efficacy of treatment on Week 2, 4, 8 and 12 as Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse, Very Much Worse and missing.
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Weeks 2, 4, 8 and 12
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Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
Time Frame: Baseline (Day 1), Weeks 2, 4, 8 and 12
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Tolerability was assessed by the participants based on a 0-3 point rating scale for stinging/burning (S/B) and pruritus of the face (0- None, 1- Slight, 2- Moderate and 3- Strong).
A shift table was provided to deduce how the results are varying from the Baseline visit to post-baseline visits.
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Baseline (Day 1), Weeks 2, 4, 8 and 12
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Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
Time Frame: Week 12
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The product acceptability and preference questionnaire (PAP-Q ) served as a patient satisfaction score and was performed only once at the final study visit (ie, after 12 weeks (V5) or earlier in case of premature termination).
Severity of each facial acne sign and symptom (scaling, redness, dryness, burning, itching) was based on a 0-5 point rating scale (0- None, 1- Very minimal, 2- Mild, 3- Moderate, 4- Severe, 5- Very severe).
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Week 12
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Number of Treatment Adherent Participants at Week 12
Time Frame: Week 12
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The general assessment of 'overall satisfaction' with study therapy was assessed at week 12 on a 0-4 point rating scale (0-Very satisfied, 1- Satisfied, 2- Neutral, 3- Unsatisfied and 4- Very unsatisfied).
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Week 12
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Absolute Change From Baseline in Total Score as Per Dermatology Life Quality Index (DLQI) at Week 2,4,8 and 12
Time Frame: Baseline (Day 1) up to Weeks 2, 4, 8, 12
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This outcome measure was a measure of quality of life (QOL).
The DLQI was used to assess the quality of life at each visit.
Participants completed the questionnaire to evaluate how their acne has affected their life.
The DLQI is a 10 item questionnaire, which addresses feelings, daily activities, leisure, work, school, personal relationships, and treatment.
Each question was scored out of 0-3, as follows: 0- Not at all, 1- A little, 2- A lot, 3- very much, indicating 0 as the least and 3 as the best quality Index.
The sub-scale scores of 10 questions were combined and a composite score was presented.
The total score ranged from 0 to 30, 0 indicated the least and highest score indicated the best quality Index.
The DLQI was for participants with 17 to 45 years of age.
Baseline was defined at Visit 1 (Day 1).
Change from Baseline is the value at indicated time point minus the Baseline value.
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Baseline (Day 1) up to Weeks 2, 4, 8, 12
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Absolute Change From Baseline in Total Score as Per Children's Dermatology Life Quality Index (CDLQI) at Week 2,4,8 and 12
Time Frame: Baseline (Day 1) up to Weeks 2, 4, 8, 12
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This outcome measure was a measure of QOL.
The CDLQI was used to assess the quality of life at each visit.
Participants completed the questionnaire to evaluate how their acne has affected their life.
The DLQI is a 10 item questionnaire, which addresses feelings, daily activities, leisure, work, school, personal relationships, and treatment.
Each question was scored out of 0-3, as follows: 0- Not at all, 1- A little, 2- A lot, 3- very much, indicating 0 as the least and 3 as the best quality Index.
The sub-scale scores of 10 questions were combined and a composite score was presented.
The total score ranged from 0 to 30, 0 indicated the least and highest score indicated the best quality Index.
The CDLQI was for participants with 12 to 16 years of age.
Baseline was defined at Visit 1 (Day 1).
Change from Baseline is the value at indicated time point minus the Baseline value.
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Baseline (Day 1) up to Weeks 2, 4, 8, 12
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Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) Related to Study Medication
Time Frame: Up to Week 12
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Adverse events are defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Serious adverse events are defined as any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect and medically significant.
TEAEs and TESAEs were reported up to 12 weeks.
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Up to Week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 21, 2014
Primary Completion (Actual)
September 8, 2014
Study Completion (Actual)
September 8, 2014
Study Registration Dates
First Submitted
February 6, 2014
First Submitted That Met QC Criteria
February 6, 2014
First Posted (Estimate)
February 10, 2014
Study Record Updates
Last Update Posted (Actual)
August 25, 2017
Last Update Submitted That Met QC Criteria
August 24, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Acneiform Eruptions
- Sebaceous Gland Diseases
- Acne Vulgaris
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Dermatologic Agents
- Anti-Bacterial Agents
- Protein Synthesis Inhibitors
- Clindamycin
- Clindamycin palmitate
- Clindamycin phosphate
- Azelaic acid
Other Study ID Numbers
- 200398
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
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Dataset Specification
Information identifier: 200398Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: 200398Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: 200398Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: 200398Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Annotated Case Report Form
Information identifier: 200398Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: 200398Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: 200398Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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