DUAC® Early Onset Efficacy Study in Japanese Subjects

NCT02557399 | Completed Phase 4 Results

• 1 other identifier: 201884
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 15

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.

Conditions

Acne Vulgaris

Keywords

Clindamycin; Gel; Benzoyl Peroxide; Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Percent Change in Total Lesion Counts (TLs) From Baseline to 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).

  Baseline (Day 1) and Week 2

Secondary Outcomes (13)

• Percent Change From Baseline in TLs to Weeks 1, 4, 8 and 12

  Baseline (Day 1) and Week 1, 4, 8, 12

• Percent Change Form Baseline in Lesion Counts (ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12

  Baseline (Day 1) and Week 1, 2, 4, 8, 12

• Absolute Change From Baseline in Lesion Counts (TLs, ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12

  Baseline (Day 1) and Week 1, 2, 4, 8, 12

• 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

  Week 1, 2, 4, 8, 12

• Percentage of Participants With ISGA Score of 0 or 1 at Weeks 1, 2, 4, 8 and 12

  Week 1, 2, 4, 8 and 12

Study Arms (2)

Duac® fixed dose combination gel

EXPERIMENTAL

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.

Drug: Duac® fixed dose combination gel

Combination therapy: ADA 0.1% gel + CLDM 1% gel

ACTIVE COMPARATOR

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.

Drug: ADA 0.1% gel; Drug: CLDM 1% gel

Interventions

Duac® fixed dose combination gel DRUG

Duac® fixed dose combination gel containing clindamycin phosphate 1.2% and benzoyl peroxide 3%.

Duac® fixed dose combination gel

ADA 0.1% gel DRUG

ADA 0.1% gel containing 0.1% of adapalene.

Combination therapy: ADA 0.1% gel + CLDM 1% gel

CLDM 1% gel DRUG

CLDM 1% gel containing clindamycin phosphate 1.2% (1% as clindamycin).

Combination therapy: ADA 0.1% gel + CLDM 1% gel

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (15)

GSK Investigational Site

Aichi, 453-0054, Japan

Location

GSK Investigational Site

Aichi, 464-0821, Japan

Location

GSK Investigational Site

Aichi, 468-0011, Japan

Location

GSK Investigational Site

Chiba, 272-0143, Japan

Location

GSK Investigational Site

Chiba, 273-0046, Japan

Location

GSK Investigational Site

Kanagawa, 221-0825, Japan

Location

GSK Investigational Site

Kanagawa, 242-0007, Japan

Location

GSK Investigational Site

Osaka, 560-0824, Japan

Location

GSK Investigational Site

Osaka, 572-0838, Japan

Location

GSK Investigational Site

Osaka, 580-0032, Japan

Location

GSK Investigational Site

Osaka, 593-8324, Japan

Location

GSK Investigational Site

Saitama, 333-0055, Japan

Location

GSK Investigational Site

Tokyo, 133-0057, Japan

Location

GSK Investigational Site

Tokyo, 143-0023, Japan

Location

GSK Investigational Site

Tokyo, 169-0075, Japan

Location

Related Links

• IPD for this study will be made available via the Clinical Study Data Request site.

MeSH Terms

Conditions

Acne Vulgaris

Interventions

clindamycin phosphate benzoyl peroxide combination; Gels

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: September 23, 2015
• Study Start: October 7, 2015
• Primary Completion: December 17, 2015
• Study Completion: February 17, 2016
• Last Updated: August 20, 2018
• Results First Posted: February 15, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

JP (15)