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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT02058628
First received: February 6, 2014
Last updated: September 18, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Acne Vulgaris
Drug: Clindamycin + BPO
Drug: Azelaic acid
Phase 4

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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from Baseline of inflammatory lesion counts at Week 4 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    Change from baseline of inflammatory lesions (papules and pustules, including nasal lesions) in face at Week 4 will be calculated.


Secondary Outcome Measures:
  • Change from Baseline of lesion counts [ Time Frame: Baseline, Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
    Change from baseline in inflammatory lesions (papules and pustules, including nasal lesions), non-inflammatory lesions (open and closed comedones) and total lesions in face will be calculated.

  • Change from Baseline of lesions by Investigator's Static Global Assessment (ISGA) [ Time Frame: Baseline, Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
    ISGA is a 0-5 point rating scale to assess lesions

  • Time to 50% reduction in total lesion count [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline of local tolerability as assessed by investigator [ Time Frame: Baseline, Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
    Tolerability will be assessed by investigator for erythema, dryness and peeling on a 0-3 point rating scale

  • Subject's global change assessment (SGCA) of skin [ Time Frame: Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
    An SGCA will be conducted by the subject to assess the efficacy of treatment

  • Change from Baseline of local tolerability as assessed by subject [ Time Frame: Baseline, Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
    Tolerability will be assessed by subject for burning/stinging and pruritus of the face based on a 0-3 point rating scale

  • Subject satisfaction score at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Subject will give a satisfaction score in the range of 0-4 based on the overall satisfaction with the study product

  • Measured adherence to study medication at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Quality of Life Assessments [ Time Frame: Baseline, Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
    Dermatology Life Quality Index (DLQI) and Children's Dermatology Life Quality Index (CDLQI) will be used to assess the quality of life at each visit. Subjects will complete the questionnaire to evaluate how their acne has affected their life. The DLQI is for subjects with 17 to 45 years of age and the CDLQI is for subjects with 12 to 16 years of age.

  • Number of treatment related adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to Week 12 ] [ Designated as safety issue: No ]

Enrollment: 221
Study Start Date: February 2014
Study Completion Date: September 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Clindamycin + BPO
Gel containing 1.2% clindamycin and 3% BPO for once daily application
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.
Drug: Azelaic acid
Cream containing 20% azelaic acid for twice daily application

  Eligibility

Ages Eligible for Study:   12 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02058628

Locations
Germany
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70178
GSK Investigational Site
Tuebingen, Baden-Wuerttemberg, Germany, 72076
GSK Investigational Site
Augsburg, Bayern, Germany, 86179
GSK Investigational Site
Gilching, Bayern, Germany, 82205
GSK Investigational Site
Mahlow, Brandenburg, Germany, 15831
GSK Investigational Site
Duelmen, Niedersachsen, Germany, 48249
GSK Investigational Site
Duesseldorf, Nordrhein-Westfalen, Germany, 40212
GSK Investigational Site
Dessau, Sachsen-Anhalt, Germany, 06847
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39120
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24148
GSK Investigational Site
Berlin, Germany, 10783
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02058628     History of Changes
Other Study ID Numbers: 200398
Study First Received: February 6, 2014
Last Updated: September 18, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:
azelaic acid
Clindamycin
Benzoyl peroxide
Acne vulgaris

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Azelaic acid
Benzoyl Peroxide
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 22, 2014