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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acne Vulgaris

Intervention: Clindamycin + BPO (Drug); Azelaic acid (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

Official title: 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

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

Primary outcome: Change from Baseline of inflammatory lesion counts at Week 4

Secondary outcome:

Change from Baseline of lesion counts

Change from Baseline of lesions by Investigator's Static Global Assessment (ISGA)

Time to 50% reduction in total lesion count

Change from Baseline of local tolerability as assessed by investigator

Subject's global change assessment (SGCA) of skin

Change from Baseline of local tolerability as assessed by subject

Subject satisfaction score at Week 12

Measured adherence to study medication at Week 12

Quality of Life Assessments

Number of treatment related adverse events (AEs) and serious adverse events (SAEs)

Eligibility

Minimum age: 12 Years. Maximum age: 45 Years. Gender(s): Both.

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).

Locations and Contacts

GSK Investigational Site, Berlin 10783, Germany

GSK Investigational Site, Stuttgart, Baden-Wuerttemberg 70178, Germany

GSK Investigational Site, Tuebingen, Baden-Wuerttemberg 72076, Germany

GSK Investigational Site, Augsburg, Bayern 86179, Germany

GSK Investigational Site, Gilching, Bayern 82205, Germany

GSK Investigational Site, Mahlow, Brandenburg 15831, Germany

GSK Investigational Site, Duelmen, Niedersachsen 48249, Germany

GSK Investigational Site, Duesseldorf, Nordrhein-Westfalen 40212, Germany

GSK Investigational Site, Dessau, Sachsen-Anhalt 06847, Germany

GSK Investigational Site, Magdeburg, Sachsen-Anhalt 39120, Germany

GSK Investigational Site, Kiel, Schleswig-Holstein 24148, Germany

Additional Information

Starting date: February 2014
Last updated: October 23, 2014

Page last updated: August 23, 2015

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