Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 236 for:    acne AND Percent

DUAC® Early Onset Efficacy Study in Japanese Subjects

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: NCT02557399
Recruitment Status : Completed
First Posted : September 23, 2015
Results First Posted : February 15, 2018
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE June 11, 2015
First Posted Date  ICMJE September 23, 2015
Results First Submitted Date  ICMJE February 24, 2017
Results First Posted Date  ICMJE February 15, 2018
Last Update Posted Date August 20, 2018
Actual Study Start Date  ICMJE October 7, 2015
Actual Primary Completion Date December 17, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2017)
Percent Change in Total Lesion Counts (TLs) From Baseline to Week 2 [ Time Frame: Baseline (Day 1) and Week 2 ]
The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones) and total lesions (the sum of IL and non-IL) at each study visit. Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100. The Baseline value was the latest pre-dose assessment value. The non-inflammatory lesions were counted by diagnosis based on palpation of the investigator (or sub-investigator).
Original Primary Outcome Measures  ICMJE
 (submitted: September 21, 2015)
Percent Change in Total Lesion Counts (TLs) From Baseline to Week 2 [ Time Frame: Baseline and up to Week 2 ]
The investigator counts inflammatory lesions (ILs) (papules and pustules) and non-ILs (open and closed comedones) on the face, including nasal lesions. The TLs are the sum of ILs and non-ILs.
Change History Complete list of historical versions of study NCT02557399 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2017)
  • Percent Change From Baseline in TLs to Weeks 1, 4, 8 and 12 [ Time Frame: Baseline (Day 1) and Week 1, 4, 8, 12 ]
    The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones) and total lesions (the sum of IL and non-IL) at each study visit. Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100. The Baseline value was the latest pre-dose assessment value. The non-ILs were counted by diagnosis based on palpation of the investigator (or sub-investigator). A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
  • Percent Change Form Baseline in Lesion Counts (ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12 [ Time Frame: Baseline (Day 1) and Week 1, 2, 4, 8, 12 ]
    The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones). Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100. The Baseline value was the latest pre-dose assessment value. The non-ILs were counted by diagnosis based on palpation of the investigator (or sub-investigator).
  • Absolute Change From Baseline in Lesion Counts (TLs, ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12 [ Time Frame: Baseline (Day 1) and Week 1, 2, 4, 8, 12 ]
    The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones) and total lesions (the sum of IL and non-IL) at each study visit. Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. The non-ILs were counted by diagnosis based on palpation of the investigator (or sub-investigator). A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM. The Baseline value was the latest pre-dose assessment value.
  • Percentage of Participants With a Minimum of 2-grade Improvement in Investigator's Static Global Assessment (ISGA) Score From Baseline to Weeks 1, 2, 4, 8 and 12 [ Time Frame: Week 1, 2, 4, 8, 12 ]
    Responder was defined as participants with a minimum 2-grade improvement in ISGA score from Baseline. ISGA scale was scored from 0-5 (0= Clear skin with no inflammatory or non-ILs, 1= Almost clear: rare non-ILs present, with no more than rare papules, 2= Mild severity: greater than Grade 1, some non-ILs with no more than few inflammatory lesions, 3= Moderate severity: greater than Grade 2, many non-ILS, may have some ILs, but no more than 1 small nodular lesion, 4= Severe: greater than Grade 3, up to many non-ILs and ILs, but no more than a few nodular lesions, 5= Very severe: many non -ILs and ILs and more than a few nodular lesions. May have cystic lesions). Percentage of participants was calculated by dividing number of participants with 2-grade improvement in ISGA score from Baseline by total number of participants value multiplied by 100.
  • Percentage of Participants With ISGA Score of 0 or 1 at Weeks 1, 2, 4, 8 and 12 [ Time Frame: Week 1, 2, 4, 8 and 12 ]
    Responder was defined as participant with ISGA score of 0 or 1. ISGA scale was scored from 0-5 (0= Clear skin with no inflammatory or non-ILs, 1= Almost clear: rare non-ILs present, with no more than rare papules, 2= Mild severity: greater than Grade 1, some non-ILs with no more than few inflammatory lesions, 3= Moderate severity: greater than Grade 2, many non-ILS, may have some ILs, but no more than 1 small nodular lesion, 4= Severe: greater than Grade 3, up to many non-ILs and ILs, but no more than a few nodular lesions, 5= Very severe: many non -ILs and ILs and more than a few nodular lesions. May have cystic lesions). Percentage of participants was calculated by dividing number of participants with 0-1 ISGA score post Baseline by total number of participants value multiplied by 100.
  • Percentage of Participants With at Least 50% Reduction in Lesion Counts (TLs, ILs and Non-ILs) From Baseline at Weeks 1, 2, 4, 8 and 12 [ Time Frame: Week 1, 2, 4, 8 and 12 ]
    Responder was defined as participants with at least a 50% reduction in TLs, ILs and non-ILs. Data for number of participants is reported. Percentage of participants was calculated by dividing number of responders by total number of participants value multiplied by 100.
  • Number of Participants With Treatment Adherence Rate at Weeks 1, 2, 4, 8 and 12 [ Time Frame: Week 1, 2, 4, 8 and 12 ]
    The investigator (or sub-investigator), the product storage manager, or the blinded coordinator dispensed a study compliance log to record participant's compliance with investigational product application from Baseline to the end of study treatment. The product storage manager or the blinded coordinator evaluated the participant's compliance with study treatment, using the study compliance log at each visit, and recorded the compliance data in the eCRF.
  • Number of Participants Who Continued Treatment at Weeks 1, 2, 4, 8 and 12 [ Time Frame: Up to Week 12 ]
    Number of participants who continued the treatment till Week 12 was measured. Overall data for participants who have not missed any dose during the treatment period has been reported.
  • Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12 [ Time Frame: Week 1, 2, 4, 8 and 12 ]
    Participants had to rate each question on a 5-point scale of 0 to 4 (4: yes, very easy to use, 3: yes, easy, 2: slightly easy, 1: slightly difficult, 0: No) where larger score indicates more preferable participant's feeling. There were 5 questions in the questionnaire: ease of application, comfort, satisfaction with treatment (ST), comparison with prior therapies (CPT) and willingness to continue using the product (WCP).
  • Change From Baseline in Quality of Life (QoL) Score at Week 2, 4, 8 and 12 [ Time Frame: Baseline(Day 1) and Week 2, 4, 8 and 12 ]
    QOL questionnaire was assessed using Skindex-16 with 16 questions in 3 multi-item scales: symptoms, emotions and functioning for the past week: skin condition-itching, burning or stinging, hurting, being irritated, persistence/reoccurrence of skin condition, worry about condition, appearance of skin, frustration about skin, embarrassment about skin, being annoyed about your skin, feeling depressed about skin, effects of your skin on your interactions with others, effects of your skin condition on your desire to be with people, skin condition making it hard to show affection, effects of your skin condition on your daily activities and skin condition making it hard to work or do what you enjoy. Data for adjusted mean has been reported. The Baseline value was the latest pre-dose assessment value. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Scores range from 0-never bothered to 100-always bothered.
  • Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Week 12 ]
    An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate. For liver injury and impaired liver function, alanine aminotransferase greater than or equal to (>=)3 times upper limit of normal (ULN) and total bilirubin >=2xULN (less than [>] 35% direct) was defined.
  • Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging [ Time Frame: Week 1, 2, 4, 8 and 12 ]
    Local tolerability score for erythema (no redness, faint red or pink coloration, barely perceptible, light red or pink coloration, medium red coloration, beet red coloration), dryness (none, barely perceptible dryness with no flakes or fissure formation, easily perceptible dryness with no flakes or fissure formation, easily noted dryness and flakes but no fissure formation, easily noted dryness with flakes and fissure formation), peeling (no peeling, mild localized peeling, mild and diffuse peeling, moderate and diffuse peeling, moderate to prominent, dense peeling) and itching and burning/stinging (normal-no discomfort, noticeable discomfort that causes intermittent awareness, continuous awareness, intermittent awareness and interferes occasionally with normal daily activities, a definite continuous discomfort that interferes with normal daily activities) was assessed on a scale of 0 to 4 (0= absent, 1= slight, 2= mild, 3= moderate and 4= severe).
  • Number of Participants With Severity of AEs [ Time Frame: Up to Week 12 ]
    The severity of AEs was assessed by the investigator; events were assigned to one of the following categories: mild, an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; moderate, an event that was sufficiently discomforting to interfere with normal everyday activities; and severe, an event that prevented normal everyday activities.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2015)
  • Percent change in TLs from Baseline to Weeks 1, 4, 8 and 12 [ Time Frame: Baseline, Weeks 1, 4, 8 and 12 ]
    The investigator counts ILs (papules and pustules) and non-ILs (open and closed comedones) on the face, including nasal lesions. The TLs are the sum of ILs and non-ILs.
  • Percent change in lesion counts (ILs and non-ILs) form Baseline to Weeks 1, 2, 4, 8 and 12 [ Time Frame: Baseline, Weeks 1, 2, 4, 8 and 12 ]
    The investigator counts ILs (papules and pustules) and non-ILs (open and closed comedones) on the face, including nasal lesions.
  • Absolute change in lesion counts (TLs, ILs and non-ILs) from Baseline to Weeks 1, 2, 4, 8 and 12 [ Time Frame: Baseline, Weeks 1, 2, 4, 8 and 12 ]
    The investigator counts of ILs (papules and pustules) and non-ILs (open and closed comedones) on the face, including nasal lesions. The TLs are the sum of ILs and non-ILs.
  • Proportion of subjects who have a minimum of 2-grade improvement in investigator's static global assessment (ISGA) score from Baseline to Weeks 1, 2, 4, 8 and 12 [ Time Frame: Baseline, Weeks 1, 2, 4, 8 and 12 ]
    The investigator evaluates the acne severity of the subject's face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or non-ILs; 5= very severe: many non-ILs and ILs and more than a few nodular lesions [NLs], may have cystic lesions.
  • Proportion of subjects who have ISGA score of 0 or 1 at Weeks 1, 2, 4, 8 and 12 [ Time Frame: Weeks 1, 2, 4, 8 and 12 ]
    The investigator evaluates the acne severity of the subject's face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or non-ILs; 5= very severe: many non-ILs and ILs and more than a few NLs, may have cystic lesions.
  • Proportion of subjects who have at least 50% reduction in TLs from Baseline at Weeks 1, 2, 4, 8 and 12 [ Time Frame: Baseline, Weeks 1, 2, 4, 8 and 12 ]
    The investigator counts ILs (papules and pustules) and non-ILs (open and closed comedones) on the face, including nasal lesions. The TLs are the sum of ILs and non-ILs.
  • Treatment adherence rate at Weeks 1, 2, 4, 8 and 12 [ Time Frame: Week 1, 2, 4, 8 and 12 ]
    Treatment compliance sheets are recorded by subjects daily. The study staff in each investigation sites, not investigator/sub-investigator, will check the sheet at indicated study visits.
  • Continuous treatment rate at Weeks 1, 2, 4, 8 and 12 [ Time Frame: Weeks 1, 2, 4, 8 and 12 ]
    Treatment compliance sheets are recorded by subjects daily. The study staff in each investigation sites, not investigator/sub-investigator, will check the sheet at indicated study visits.
  • Subjects treatment preference at Weeks 1, 2, 4, 8 and 12 [ Time Frame: Week 1, 2, 4, 8 and 12 ]
    Treatment preference questionnaires are completed by subjects at indicated study visits and rate the questions on a 5-points scale. The questionnaires comprised of five preference questions.
  • Quality of life (QoL) score at Baseline, Weeks 2, 4, 8 and 12 [ Time Frame: Baseline, Weeks 2, 4, 8 and 12 ]
    Skindex-16 questionnaire for QoL is used in dermatological disease consisting of 16 questions covering: burden of symptoms (four items), functioning (five items) and emotional (seven items) domains.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DUAC® Early Onset Efficacy Study in Japanese Subjects
Official Title  ICMJE Clinical Evaluation of Efficacy at 2 Weeks of Duac® Fixed Dose Combination Gel in Treatment of Facial Acne Vulgaris in Japanese Subjects
Brief Summary This is a multicentre, randomized, single-blind (investigator is blinded), active (the combination therapy of adapalene [ADA] and clindamycin [CLDM])-controlled and parallel-group study in Japanese subjects with facial acne vulgaris. The purpose of this study is to evaluate the efficacy, safety and tolerability of CLDM 1 percent (%)-benzoyl peroxide 3% (Duac®: trademark owned by GlaxoSmithKline) once daily fixed dose combination gel versus combination therapy of ADA 0.1% gel and CLDM 1% gel in the topical treatment of facial acne vulgaris for 12 weeks. A total of 400 subjects will be screened for enrolment. Subjects will use Duac® fixed dose combination gel with quantity sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) or combination therapy of ADA 0.1% gel with quantity sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks.
Detailed Description Duac® is a registered trademark of Stiefel Laboratories, Inc., a GSK company. Duac® marketed in Japan is CLDM 1%-benzoyl peroxide 3% combination gel.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: Duac® fixed dose combination gel
    Duac® fixed dose combination gel containing clindamycin phosphate 1.2% and benzoyl peroxide 3%.
  • Drug: ADA 0.1% gel
    ADA 0.1% gel containing 0.1% of adapalene.
  • Drug: CLDM 1% gel
    CLDM 1% gel containing clindamycin phosphate 1.2% (1% as clindamycin).
Study Arms  ICMJE
  • Experimental: Duac® fixed dose combination gel
    Subjects will use Duac® fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.
    Intervention: Drug: Duac® fixed dose combination gel
  • Active Comparator: Combination therapy: ADA 0.1% gel + CLDM 1% gel
    Subjects will use combination therapy of ADA 0.1% gel with quantity sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and subjects will also apply CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel should apply subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel should be applied to ILs only.
    Interventions:
    • Drug: ADA 0.1% gel
    • Drug: CLDM 1% gel
Publications * Not Provided

*   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: September 21, 2015)
350
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 17, 2016
Actual Primary Completion Date December 17, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female subjects between 12 to 45 years of age, inclusive.
  • Subjects must have had both: (a) A minimum of 17 but not more than 60 ILs (papules / pustules) on the face, including nasal lesions; (b) A minimum of 20 but not more than 150 non-ILs (open / closed comedones) on the face, including nasal lesions.
  • Subjects who have an ISGA score of 2 or greater at Baseline.
  • Female subjects of childbearing potential and women who are less than 2 years from their last menses must agree to use contraception
  • Subjects who are willing and able to follow all study procedures and to visit all scheduled evaluation points.
  • Subjects who have ability to understand and give a written informed consent form (written informed consent must be obtained also from the parent or guardian if the participant is under 20 years of age).

Exclusion Criteria:

  • Subjects who have any nodulo-cystic lesions at Baseline.
  • Female subjects who are pregnant or who are breast-feeding.
  • Subjects who have a history or presence of regional enteritis, inflammatory bowel disease (e.g. ulcerative colitis, pseudomembranous colitis, chronic diarrhoea, antibiotic-associated colitis or bloody diarrhoea) or similar symptoms.
  • Subjects who used any of the following agents within 2 weeks prior to Baseline: topical antibiotics on the face or systemic antibiotics; topical anti-acne medications (e.g. Benzoyl peroxide, azelaic acid, resorcinol, salicylates etc.); abradants, facials, peels, masks containing glycolic or other acids; washes, soaps, non mild facial cleansers containing benzoyl peroxide, salicylic acid or sulfacetamide sodium; moisturizers containing retinol, salicylic acid or alpha or beta-hydroxy acids (except additive agent); astringents and toner.
  • Subjects who used any of the following agents on the face or performed the following procedure within 4 weeks prior to baseline: topical corticosteroids applied onto face (use of inhaled, intra-articular or intra-lesional steroids other than for facial acne is acceptable); facial procedure (such as chemical and laser peel, microdermabration, blue light treatment, etc.).
  • Subjects who used systemic retinoids within the previous 6 months or topical retinoids within 6 weeks prior to Baseline.
  • Subjects who received treatment with estrogens, androgens or anti-androgenic agents within the previous 12 weeks (subjects who have been treated with the above agents for more than 12 consecutive weeks prior to start of investigational product are allowed to enrol as long as they do not expect to change dose, drug or discontinue use during the study).
  • Subjects who are using any medication that in the opinion of the investigator may affect this clinical study or evaluation of the study.
  • Subjects who plan to use medications that are reported to exacerbate acne (such as vitamin D and vitamin B12, corticosteroids, androgens, haloperidol, halogens, lithium, hydantoin and Phenobarbital).
  • Subjects who have a known hypersensitivity or have had previous allergic reaction to any of the components of the investigational product.
  • Subjects who have used investigate therapy within the previous 12 weeks or plan to participate in another clinical study at the same time.
  • Subjects who participated in another Japanese clinical study planned by GlaxoSmithKline K.K. in the development of investigational products for acne vulgaris.
  • Subjects with a history of substance abuse (alcohol or drugs) or substance dependence within 12 months prior to screening.
  • Subjects who have medical history suggestive of an immunocompromized status.
  • Subjects who are employees of a GlaxoSmithKline, an investigator or clinical research organization involved in the study or any immediate family member of an employee involved in the study.
  • Subjects who have any other condition that would put the subject at unacceptable risk for participation in the 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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02557399
Other Study ID Numbers  ICMJE 201884
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: https://clinicalstudydatarequest.com
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date July 2018

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