Comparison of the Efficacy and Safety of Clindamycin + Benzoyl Peroxide Formulation With Azelaic Acid Formulation in the Treatment of Acne Vulgaris

NCT ID: NCT02058628

Last Updated: 2017-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 222 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-21
• Study Completion Date: 2014-09-08

Brief Summary

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm 1

A total of 110 subjects will receive clindamycin + BPO once daily in the evening for 12 weeks as per the randomization schedule.

Group Type: EXPERIMENTAL

Clindamycin + BPO

Intervention Type: DRUG

Gel containing 1.2% clindamycin and 3% BPO for once daily application

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.

Group Type: EXPERIMENTAL

Azelaic acid

Intervention Type: DRUG

Cream containing 20% azelaic acid for twice daily application

Interventions

Clindamycin + BPO

Gel containing 1.2% clindamycin and 3% BPO for once daily application

Intervention Type: DRUG

Azelaic acid

Cream containing 20% azelaic acid for twice daily application

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Stuttgart, Baden-Wurttemberg, Germany

GSK Investigational Site

Tübingen, Baden-Wurttemberg, Germany

GSK Investigational Site

Augsburg, Bavaria, Germany

GSK Investigational Site

Gilching, Bavaria, Germany

GSK Investigational Site

Mahlow, Brandenburg, Germany

GSK Investigational Site

Duelmen, Lower Saxony, Germany

GSK Investigational Site

Düsseldorf, North Rhine-Westphalia, Germany

GSK Investigational Site

Dessau, Saxony-Anhalt, Germany

GSK Investigational Site

Magdeburg, Saxony-Anhalt, Germany

GSK Investigational Site

Kiel, Schleswig-Holstein, Germany

GSK Investigational Site

Berlin, , Germany

Countries

Germany

Study Documents

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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Other Identifiers

200398

Identifier Type: -

Identifier Source: org_study_id