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Evaluation of the Effectiveness, Safety, and Tolerability of Duac Akne Gel and Epiduo Gel in the Treatment of Facial Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00757523
Recruitment Status : Completed
First Posted : September 23, 2008
Last Update Posted : August 17, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )

Tracking Information
First Submitted Date  ICMJE September 21, 2008
First Posted Date  ICMJE September 23, 2008
Last Update Posted Date August 17, 2017
Actual Study Start Date  ICMJE September 10, 2008
Actual Primary Completion Date April 24, 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2017)
Percent change in inflammatory lesion count from Baseline to Week 12 [ Time Frame: Baseline (Day 1) and Week 12 ]
The efficacy assessor performed a count of inflammatory lesions (papules and pustules, including nasal lesions) each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Week 12.
Original Primary Outcome Measures  ICMJE
 (submitted: September 21, 2008)
Outcome Measure: To evaluate the efficacy of Duac Akne Gel compared with Epiduo Gel in the treatment of facial acne vulgaris. [ Time Frame: 12 Weeks ]
Change History Complete list of historical versions of study NCT00757523 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2017)
  • Percentage of participants who achieved treatment success, defined as improvement of 2 grades or more in their Investigator Static Global Assessment (ISGA) acne severity scale from Baseline to Week 12 [ Time Frame: Week 12 ]
    ISGA success was defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. The area considered for assessment must be confined to the face. Acne severity of the participant's face was assessed by the assessor using the ISGA scale, ranging from 0 to 5 where 0=Clear skin with no inflammatory or non-inflammatory lesions. ;1=almost clear: Rare non-inflammatory lesions with no more than one small inflammatory lesion ;2=mild: Some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions). ;3=moderate: Up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion; 4=severe: Up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions and 5= Very Severe: Many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. The higher score indicated more severe lesions.
  • Time to 2-grade improvement in ISGA from Baseline [ Time Frame: Week 12 ]
    ISGA success was defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. Time to ISGA success from Baseline was analyzed using Kaplan-Meier Estimate of time. Baseline was defined as the value at Day 1 (Visit 1). Participants with missing week 12 evaluations were considered failures.
  • Percent change in total lesion count from Baseline to week 12 [ Time Frame: Baseline (Day 1) and Week 12 ]
    The efficacy assessor performed a count of total lesions at each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Week 12.
  • Absolute change in inflammatory lesion count from Baseline to Weeks 1, 2, 4, 8 [ Time Frame: Baseline (Day 1) and Weeks 1, 2, 4, 8 ]
    The efficacy assessor performed a count of inflammatory lesions (papules and pustules, including nasal lesions) each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Weeks 1, 2, 4, 8.
  • Absolute change in inflammatory lesion count from Baseline to Week 12. [ Time Frame: Baseline (Day 1) and Week 12 ]
    The efficacy assessor performed a count of inflammatory lesions (papules and pustules, including nasal lesions) each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Week 12.
  • Absolute change in total lesion count from Baseline to Weeks 1, 2, 4, 8 [ Time Frame: Baseline (Day 1) and Weeks 1, 2, 4, 8 ]
    The efficacy assessor performed a count of total lesions at each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Weeks 1, 2, 4, 8.
  • Absolute change in total lesion count from Baseline to Week 12 [ Time Frame: Baseline (Day 1) and Week 12 ]
    The efficacy assessor performed a count of total lesions at each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Week 12.
  • Percentage of participants who achieved treatment success from Baseline to Weeks 1, 2, 4, and 8 [ Time Frame: Weeks 1, 2, 4, and 8 ]
    ISGA success was defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. Acne severity of the participant's face was assessed by the assessor using the ISGA scale, ranging from 0 to 5 where 0= Clear skin with no inflammatory or non-inflammatory lesions and 5= Very Severe: Many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. The higher score indicated more severe lesions. The area considered for the ISGA was confined to the face. Data for percentage of participants who achieved treatment success from Baseline to Weeks 1, 2, 4, and 8 was not collected.
  • Absolute change in non-inflammatory lesion count from Baseline to Weeks 1 2, 4,8 [ Time Frame: Baseline (Day 1) and Weeks 1,2,4,8 ]
    The efficacy assessor performed a count of non-inflammatory lesions (open and closed comedones, excluding nasal lesions) each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Weeks 1, 2, 4, 8.
  • Absolute change in non-inflammatory lesion count from Baseline to Week 12 [ Time Frame: Baseline (Day 1) and Week 12 ]
    The efficacy assessor performed a count of non-inflammatory lesions (open and closed comedones, excluding nasal lesions) each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Week 12.
  • Percent change in non-inflammatory lesion count from Baseline to Weeks 1, 2, 4, 8 [ Time Frame: Baseline (Day 1) and Weeks 1, 2, 4, 8 ]
    The efficacy assessor performed a count of non-inflammatory lesions (open and closed comedones, excluding nasal lesions) each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Weeks 1, 2, 4, 8.
  • Percent change in non-inflammatory lesion count from Baseline to Week 12 [ Time Frame: Baseline (Day 1) and Week 12 ]
    The efficacy assessor performed a count of non-inflammatory lesions (open and closed comedones, excluding nasal lesions) each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Week 12.
  • Percent change in inflammatory lesion count from Baseline to Weeks 1, 2, 4, and 8 [ Time Frame: Baseline (Day 1) and Weeks 1, 2, 4, and 8 ]
    The efficacy assessor performed a count of inflammatory lesions (papules and pustules, including nasal lesions) each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Weeks 1, 2, 4, and 8.
  • Percent change in total lesion count from Baseline to Weeks 1, 2, 4, and 8 [ Time Frame: Baseline (Day 1) and Weeks 1, 2, 4, and 8 ]
    The efficacy assessor performed a count of total lesions at each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Weeks 1, 2, 4, and 8.
  • Time to reach 50 percent reduction in inflammatory lesion counts from Baseline [ Time Frame: Week 12 ]
    Time to reach 50 percent reduction in inflammatory lesion counts (papules and pustules, including nasal lesions) from Baseline was analyzed using Kaplan-Meier Estimate of time. Baseline was defined as the value at Day 1 (Visit 1).
  • Time to reach 50 percent reduction in non-inflammatory lesion counts from Baseline [ Time Frame: Week 12 ]
    Time to reach 50 percent reduction in non-inflammatory lesion counts ((open and closed comedones, excluding nasal lesions) from Baseline was analyzed using Kaplan-Meier Estimate of time. Baseline was defined as the value at Day 1 (Visit 1).
  • Time to reach 50 percent reduction in total lesion counts from Baseline [ Time Frame: Week 12 ]
    Time to time to reach 50 percent reduction in total lesion counts from Baseline was analyzed using Kaplan-Meier Estimate of time. Baseline was defined as the value at Day 1 (Visit 1).
  • Percentage of participants who had a Subject's Global Change Assessment score (SGAC) of 0 or 1 at Weeks 1, 2, 4, 8, and 12 [ Time Frame: Upto Week 12 ]
    SGCA is measured on a scale (Clear, Almost Clear, Mild, Moderate, Severe, Very Severe) with Clear being best and Very Severe being worst. The area considered for the ISGA was confined to the face. Data for percentage of participants who had a SGAC of 0 or 1 at Weeks 1, 2, 4, 8, and 12 was not collected.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2008)
Outcome Measure: To evaluate the safety and tolerability of Duac Akne Gel compared with Epiduo Gel. [ Time Frame: 12 Weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Effectiveness, Safety, and Tolerability of Duac Akne Gel and Epiduo Gel in the Treatment of Facial Acne Vulgaris
Official Title  ICMJE A Multi-center, Randomized, Evaluator-blind, Parallel-group Evaluation of the Efficacy, Safety, and Tolerability of Duac Akne Gel and Epiduo Gel in the Topical Treatment of Facial Acne Vulgaris
Brief Summary The purpose of this study is to compare the effectiveness of two marketed products in subjects with facial acne vulgaris
Detailed Description Multiple physiopathological factors have been associated with acne vulgaris. Drug combinations are frequently used to address these factors and to improve efficacy in the treatment of acne. The current study proposes to compare a fixed-dose (once-daily) combination gel product containing benzoyl peroxide (BPO)and clindamycin against a fixed-dose (once-daily) combination gel product containing BPO and adapalene for the treatment of facial acne vulgaris.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: Epiduo Gel
    Epiduo Gel (combination of 0.1% adapalene and 2.5% benzoyl peroxide (BPO) in a gel preparation). Treatments administered once-daily in the evening for 12 weeks
  • Drug: Duac Gel
    Duac Akne Gel (combination of 1% clindamycin phosphate and 5% benzoyl peroxide (BPO) in a gel preparation). Treatments administered once-daily in the evening for 12 weeks
    Other Name: Duac Akne Gel
Study Arms  ICMJE
  • Active Comparator: Epiduo Gel
    Epiduo Gel (combination of 0.1% adapalene and 2.5% benzoyl peroxide (BPO) in a gel preparation).
    Intervention: Drug: Epiduo Gel
  • Experimental: Duac Gel
    Duac Akne Gel (combination of 1% clindamycin phosphate and 5% benzoyl peroxide (BPO) in a gel preparation).
    Intervention: Drug: Duac Gel
Publications * Zouboulis CC, Fischer TC, Wohlrab J, Barnard J, Alió AB. Study of the efficacy, tolerability, and safety of 2 fixed-dose combination gels in the management of acne vulgaris. Cutis. 2009 Oct;84(4):223-9.

*   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: August 15, 2017)
382
Original Estimated Enrollment  ICMJE
 (submitted: September 21, 2008)
400
Actual Study Completion Date  ICMJE June 24, 2009
Actual Primary Completion Date April 24, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males or females 12 to 45 years of age, inclusive, in good general health.
  • Clinical diagnosis of acne vulgaris
  • Capable of understanding and willing to provide signed and dated written voluntary informed consent
  • Female subjects of childbearing potential must have a negative pregnancy test at baseline. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception
  • Subjects who have been treated with estrogens, androgens, or anti-androgenic agents for more than 12 consecutive weeks prior to the first dose of study product are allowed to enroll as long as they do not expect to change dose, drug, or discontinue use during the study.
  • The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.

Exclusion Criteria:

  • Female subjects who are pregnant, trying to become pregnant, or who are lactating.
  • 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.
  • Facial hair that may obscure the accurate assessment of acne grade.
  • 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.
  • Used topical antibiotics on the face or systemic antibiotics within the past 2 and 4 weeks, respectively.
  • Used topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra articular or intra-lesional (other than for facial acne lesions) steroids is acceptable.
  • Used systemic retinoids within the past 6 months.
  • Using drugs known to be photosensitizers (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of increased phototoxicity.
  • Using neuromuscular blocking agents. Clindamycin has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents.
  • Used topical anti-acne medications (eg, BPO, retinoids, azelaic acid, resorcinol, salicylates, sulfacetamide sodium and derivatives, glycolic acid) within the past 2 weeks.
  • Used any investigational therapy within 4 weeks of study day 1.
  • Using the following types of facial products: 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 α- or β-hydroxy acids.
  • Using 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.
  • Have had a facial procedure (chemical or laser peel, microdermabrasion, artificial ultraviolet [UV] therapy) performed by an esthetician, beautician, physician, nurse, or other practitioner, within the past 4 weeks.
  • Have a known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, adapalene, clindamycin, BPO, or excipients of the study medication.
  • Employees of a clinical research organization involved in the study, or Stiefel Laboratories, or an immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of an employee.
  • Have a member of the same household in this trial.
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 Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00757523
Other Study ID Numbers  ICMJE S194-401
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline ( Stiefel, a GSK Company )
Study Sponsor  ICMJE Stiefel, a GSK Company
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date August 2017

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