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Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne

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ClinicalTrials.gov Identifier: NCT00776919
Recruitment Status : Completed
First Posted : October 22, 2008
Results First Posted : January 30, 2012
Last Update Posted : November 23, 2016
Sponsor:
Collaborators:
Rho, Inc.
Quintiles, Inc.
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )

Tracking Information
First Submitted Date  ICMJE October 21, 2008
First Posted Date  ICMJE October 22, 2008
Results First Submitted Date  ICMJE December 21, 2011
Results First Posted Date  ICMJE January 30, 2012
Last Update Posted Date November 23, 2016
Study Start Date  ICMJE October 2008
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2011)
  • Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 [ Time Frame: Baseline (Day 1) and Week 12 ]
    During each study visit, investigators/assessors evaluated acne severity of the participants' faces using the ISGA scale: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L.
  • Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts [ Time Frame: Baseline (Day 1) and Week 12 ]
    During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules [small inflamed elevation of the skin that is filled with pus], papules [solid elevation of skin with no visible fluid], nodules [larger than papules with significant depth]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin). Missing values were imputed using the last observation carried forward (LOCF) method.
  • Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts [ Time Frame: Baseline (Day 1) and Week 12 ]
    During each study visit, trained study personnel at every investigational center assessed the non-inflammatory (open comedones [blackheads] and closed comedones [whiteheads]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin).
  • Mean Change From Baseline to Week 12 in Total Lesion Counts [ Time Frame: Baseline (Day 1) and Week 12 ]
    During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts.
Original Primary Outcome Measures  ICMJE
 (submitted: October 21, 2008)
Acne lesion counts and Investigator's Static Global Assessment (ISGA). [ Time Frame: Baseline, Weeks 2, 4, 8 and 12 ]
Change History Complete list of historical versions of study NCT00776919 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2011)
  • Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory) [ Time Frame: Baseline (Day 1) and Week 12 ]
    During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 12 was calculated as the value at Week 12 minus the value at Baseline divided by the Baseline value * 100.
  • Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12 [ Time Frame: Week 12 ]
    During each study visit, participants evaluated their facial acne (excluding the scalp) using the SGA scale: 0=free of acne, with only an occasional blackhead/whitehead; 1=several blackheads/whiteheads and small pimples, no tender deep-seated bumps/cysts; 2=several to many blackheads/whiteheads and small to medium-sized pimples, one deep-seated bump/cyst; 3=many blackheads/whiteheads, many medium- to large-sized pimples, few deep-seated bumps/cysts; 4=presence of blackheads/whiteheads, several to many medium- to large-sized pimples, deep-seated bumps/cysts dominate.
  • Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12 [ Time Frame: Week 12 ]
    During each study visit, investigators/assessors evaluated the acne severity of participants' faces using the ISGA scal: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L.
  • Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure [ Time Frame: Baseline (Day 1) and Week 12 ]
    Systolic and diastolic blood pressure were measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.
  • Mean Change From Baseline to Week 12 in Temperature [ Time Frame: Baseline (Day 1) and Week 12 ]
    Temperature was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.
  • Mean Change From Baseline to Week 12 in Pulse Rate [ Time Frame: Baseline (Day 1) and Week 12 ]
    Pulse rate was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.
  • Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling [ Time Frame: Baseline; Weeks 2, 4, 8, and 12 ]
    Erythema (Er, redness), dryness (Dr), and peeling (Pn), were evaluated independently by the investigator as: 0 (absent)=no Er, Dr, or Pn; 1 (slight)=faint red/pink coloration (col.), barely perceptible Dr with no flakes or fissure, mild localized Pn; 2 (mild)=light red/pink col., perceptible Dr with no flakes/fissure, mild and diffuse Pn; 3 (moderate)=medium red col., easily noted Dr and flakes but no fissure; 4 (severe)=beet red col., Dr with flakes and fissure, prominent dense Pn. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the the value at Baseline.
  • Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging [ Time Frame: Baseline; Weeks 2, 4, 8, and 12 ]
    Itching and burning/stinging (piercing pain) were evaluated independently by the investigator as: 0 (none)=normal, no discomfort; 1 (slight)=noticeable discomfort that caused intermittent awareness; 2 (moderate)=noticeable discomfort that caused intermittent awareness and interfered occasionally with normal daily activities; 3 (strong)=definite continuous discomfort that interfered with normal daily activities. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the value at Baseline.
  • Mean Duration of Study Product Use [ Time Frame: Baseline (Day 1) through Week 12 ]
    Mean duration of study product use was calculated as the average total duration inclusive of missed applications of the study product.
  • Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation [ Time Frame: Baseline (Day 1) through Week 12 ]
    An AE included, but was not limited to, any clinically significant worsening of a pre-existing condition; an event occurring from overdose (i.e., a dose higher than that indicated in the protocol) of the study product, whether accidental or intentional; an event occurring from abuse (e.g., use for nonstudy reasons) of the study product; or an event that was associated with the discontinuation of the use of the study product.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2008)
Local tolerability and adverse events [ Time Frame: Baseline, Weeks 2, 4, 8 and 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne
Official Title  ICMJE A Phase 3 Multicenter, Randomized, Double-Blind, Active And Vehicle-Controlled Study Of The Safety And Efficacy Of A Clindamycin / Benzoyl Peroxide Gel Versus Clindamycin Gel Versus Benzoyl Peroxide Gel Versus Vehicle Gel In Subjects With Acne Vulgaris
Brief Summary This is a Randomized, Double-Blind, Controlled Study to evaluate the Safety and Efficacy of a clindamycin / benzoyl peroxide gel in Subjects with Acne Vulgaris
Detailed Description A multicenter, randomized, double-blind, comparator and vehicle-controlled study in subjects with acne vulgaris. Approximately 1320 subjects will be enrolled. Subjects will be randomized to 1 of 4 parallel study groups in a 1:1:1:1 ratio (clindamycin / benzoyl peroxide gel:clindamycin gel:BPO gel:vehicle gel).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: clindamycin / benzoyl peroxide gel
    Once a day application to the face
  • Drug: clindamycin gel
    Once a day application to the face
  • Drug: BPO gel
    Once a day application to the face
  • Drug: vehicle gel
    Once a day application to the face
Study Arms  ICMJE
  • Experimental: 1
    clindamycin / benzoyl peroxide gel
    Intervention: Drug: clindamycin / benzoyl peroxide gel
  • Active Comparator: 2
    Clindamycin gel
    Intervention: Drug: clindamycin gel
  • Active Comparator: 3
    BPO gel
    Intervention: Drug: BPO gel
  • Placebo Comparator: 4
    vehicle gel
    Intervention: Drug: vehicle gel
Publications * Eichenfield LF, Alió Sáenz AB. Safety and efficacy of clindamycin phosphate 1.2%-benzoyl peroxide 3% fixed-dose combination gel for the treatment of acne vulgaris: a phase 3, multicenter, randomized, double-blind, active- and vehicle-controlled study. J Drugs Dermatol. 2011 Dec;10(12):1382-96.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 9, 2012)
1315
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2008)
1320
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Be 12 to 45 years of age, inclusive, and in good general health.
  • Clinical diagnosis of acne vulgaris
  • Females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product.
  • Have the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
  • Have the ability to understand and sign a written informed consent form, which must be completed prior to study specific tasks being performed. Subjects under the legal age of consent in the state/province/country where the study is conducted must provide assent and have the written informed consent of a parent or guardian.

Exclusion Criteria:

  • Are pregnant or breast-feeding.
  • Have a history or presence of other conditions that may increase the risk of the subject participating in the study and/or affect the evaluated outcomes.
  • Used topical antibiotics on the face or used systemic antibiotics within the past 2 weeks.
  • Used topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular, or intra-lesional steroids other than for facial acne is acceptable.
  • Used systemic retinoids within the past 6 months or topical retinoids within the past 6 weeks.
  • Received treatment with estrogens (including oral, implanted, injected and topical contraceptives), androgens, or anti-androgenic agents for 12 weeks or less immediately prior to starting study product. Subjects who have been treated with estrogens, as described above, androgens, or anti-androgenic agents for more than 12 consecutive weeks prior to start of study product are allowed to enroll as long as they do not expect to change dose, drug, or discontinue use during the study.
  • Used topical anti-acne medications (eg, BPO, azelaic acid, resorcinol, salicylates, etc.) within the past 2 weeks.
  • Used abradents or facial procedures, within the past 2 weeks.
  • Use medications that may exacerbate acne.
  • Have a known hypersensitivity or have had previous allergic reaction to any of the active components, lincomycin, or excipients of the study product.
  • Used any investigational therapy within the past 4 weeks, or currently participating in another clinical study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belize,   Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00776919
Other Study ID Numbers  ICMJE 114677
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Responsible Party GlaxoSmithKline ( Stiefel, a GSK Company )
Study Sponsor  ICMJE Stiefel, a GSK Company
Collaborators  ICMJE
  • Rho, Inc.
  • Quintiles, Inc.
  • GlaxoSmithKline
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP