W0261-101: A Phase 1, Single Center, Randomized, Open-Label Study to Evaluate the Bioavailability of Clindamycin From Clindamycin 1%-Benzoyl Peroxide 3% Gel, Topical Gel (Clindamycin 1%- Benzoyl Peroxide 5%), and Once Daily Gel (Clindamycin 1%-Benzoyl Peroxide 5%) in Subjects With Acne

NCT01132443 | Completed Phase 1

• 1 other identifier: 115902
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was conducted to determine if the bioavailability of clindamycin and its metabolite clindamycin sulfoxide are altered by the concentration of BPO or the absence of methylparaben. This study compared the investigational study product and 2 marketed products:

• CLN 1%-BPO 3% Gel (clindamycin 1%-BPO 3%), methylparaben-free
• Topical Gel (clindamycin 1%-BPO 5%), methylparaben-preserved (Topical Gel-MP)
• Once Daily Gel ((clindamycin 1%-BPO 5%), methylparaben-free (Topical Gel-MPF)

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Clindamycin plasma concentrations

  Plasma concentrations of clindamycin in subjects with acne vulgaris

  Baseline to Day 6

Secondary Outcomes (1)

• Clindamycin sulfoxide plasma concentrations

  Baseline/Day 1, Day 2, 3, 4, and 5 (pre-dose and 1, 2, 4, 6, 8, 12, and 24 hours post dost - Day 6)

Study Arms (3)

Clindamycin 1%-Benzoyl Peroxide (BPO) 3% Gel,

EXPERIMENTAL

Apply topically once daily; clindamycin (CLN); benzoyl peroxide (BPO); methylparaben-free (MPF)

Drug: Clindamycin 1%-Benzoyl Peroxide (BPO) 3% Gel,

Duac/ formulation 1

ACTIVE COMPARATOR

Apply topically once daily, Topical Gel (CLN 1%-BPO 5%), methylparaben-preserved

Drug: Clindamycin 1%-Benzoyl Peroxide (BPO) 3% Gel,

Duac/ formulation 2

ACTIVE COMPARATOR

Apply topically once daily, Duac Once Daily Gel (CLN 1%-BPO 5%), MPF

Drug: Clindamycin 1%-Benzoyl Peroxide (BPO) 3% Gel,

Interventions

Clindamycin 1%-Benzoyl Peroxide (BPO) 3% Gel, DRUG

Apply topically once daily

Clindamycin 1%-Benzoyl Peroxide (BPO) 3% Gel,; Duac/ formulation 1; Duac/ formulation 2

Eligibility Criteria

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

You may qualify if:

• Capable of understanding and willing to provide signed and dated written voluntary informed consent (and HIPAA authorization) before any protocol-specific procedures were performed. Subjects under the legal age of consent in the state where the study was conducted must have provided assent and have had the written informed consent of a parent or guardian.
• Male or female 12 to 45 years of age at time of consent.
• Moderate-to-severe facial acne, defined as an ISGA score of 3 or greater.
• Able to complete the study and to comply with study instructions.
• Sexually-active females of childbearing potential participating in the study must have agreed to use a medically-acceptable method of contraception while receiving protocol-assigned product. A woman of childbearing potential was defined as one who is biologically capable of becoming pregnant, including perimenopausal women who are less than 2 years from their last menses. Acceptable contraceptive methods included the following:
• Hormonal contraception, including oral, injectable, or implantable methods started at least 3 months prior to screening. If hormonal contraception was started less than 3 months prior to screening, then a form of nonhormonal contraception should have been added until the third continuous month of hormonal contraception had been completed.
• Two forms of reliable nonhormonal contraception, to include the use of either an intrauterine device plus a reliable barrier method or 2 reliable barrier methods. Reliable barrier methods include condoms or diaphragms. A cervical cap is also a reliable barrier method, provided the female subject has never given birth vaginally. The combined use of a condom and spermicide constitute 2 forms of acceptable nonhormonal contraception, provided that they are both used properly. The use of spermicide alone and the improper use of condoms are inferior methods of contraception. Subjects with surgical sterilization, including tubal sterilization or partner's vasectomy, must have used a form of nonhormonal contraception. A barrier method or sterilization plus spermicide was acceptable.
• Women who were not currently sexually active must have agreed to use a medically-acceptable method of contraception should they have become sexually active while participating in the study.

You may not qualify if:

• Female who was pregnant, trying to become pregnant, or breast feeding.
• Participation in any investigational study within 4 weeks of Day 1 or who were scheduled to participate in another investigational study in the next 2 weeks.
• Used prohibited medications within specified time period before Day 1.
• Currently using any medication that, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk.
• History or evidence of skin conditions other than acne (eg, eczema, rosacea, seborrheic dermatitis, birthmarks, tattoos) that would interfere with study evaluations.
• History or presence of regional enteritis or inflammatory bowel disease (eg, ulcerative colitis, pseudomembranous colitis, chronic diarrhea, celiac disease, Crohn's disease, or history of antibiotic-associated colitis) or similar symptoms.
• Had any major illness within 4 weeks of Day 1.
• Anticipated need for surgery or hospitalization during the study.
• Blood donation, or equivalent blood loss (\~480 mL), within 3 months of Day 1.
• Anemia or any other systemic disease condition for which a loss of 120 mL of blood over a 1-week period may put the subject at undue risk.
• Considered immunocompromised.
• Currently suffering from any disease or condition that, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk.
• Current smoker or smoker with less than 4 weeks abstinence from smoking and nicotine-containing products.
• Anticipated need to engage in activities or exercise that would cause profuse sweating during the study.
• Required or desired excessive or prolonged exposure to ultraviolet light (eg, sunlight, or tanning beds) during the study.

Sponsors & Collaborators

• Stiefel, a GSK Company: lead
• GlaxoSmithKline: collaborator

Related Publications (1)

• Jones TM, Jasper S, Alio Saenz AB. Bioavailability of Clindamycin From a New Clindamycin Phosphate 1.2%-Benzoyl Peroxide 3% Combination Gel. Clin Pharmacol Drug Dev. 2013 Jan;2(1):33-47. doi: 10.1002/cpdd.7. Epub 2013 Mar 4.

  PMID: 27121558 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
• Results for study 115902 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Clindamycin; Benzoyl Peroxide; Gels

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2010
• First Posted: May 28, 2010
• Study Start: May 6, 2010
• Primary Completion: June 12, 2010
• Study Completion: June 12, 2010
• Last Updated: June 16, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share