A Study Comparing Combination Clindamycin Phosphate/Tretinoin Gel Alone Versus With Benzoyl Peroxide Foaming Cloths for Facial Acne

NCT01422785 | Unknown Phase 4 DMC

• 1 other identifier: GCO 10-1602
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

There are many different factors that cause acne. So combination treatment using different medications that can address these different factors is commonly used to treat acne. Fixed-dose combination clindamycin phosphate 1.2% and tretinoin 0.025% gel and benzoyl peroxide 6% foaming cloths are both used to treat acne. This study will evaluate the use of the medications when used together.

Conditions

Acne Vulgaris

Keywords

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Change in PGA scores of patients using combination clindamycin phosphate 1.2%/tretinoin 0.025% gel with or without benzoyl peroxide 6% foaming cloths for facial acne

  The primary efficacy endpoint will be "Treatment Success", a static endpoint defined as a score of 0 (clear) to 1 (almost clear) at Week 12 (final study visit) by PGA scoring system.

  Weeks 2, 4, 8, 12

Secondary Outcomes (4)

• Change in Postinflammatory hyperpigmentation score at each study visit and from baseline to final visit.

  Weeks 2, 4, 8, 12

• Total number of adverse events.

  Weeks 2, 4, 8, 12

• Change in Subject Self Assessment Scoring Scale

  Weeks 2, 4, 8, 12

• Change in Acne-Specific Quality of Life Questionnaire (Acne-QoL)

  Weeks 2, 4, 8, 12

Study Arms (2)

clindamycin phosphate 1.2%/tretinoin 0.025% gel alone

ACTIVE COMPARATOR

Drug: clindamycin phosphate 1.2%/tretinoin 0.025% gel alone

clindamycin / tretinoin gel plus benzoyl peroxide

ACTIVE COMPARATOR

Drug: clindamycin phosphate 1.2%/tretinoin 0.025% gel plus benzoyl peroxide 6% foaming cloths

Interventions

clindamycin phosphate 1.2%/tretinoin 0.025% gel alone DRUG

Once daily application of the clindamycin phosphate 1.2%/tretinoin 0.025% gel in the evening

clindamycin phosphate 1.2%/tretinoin 0.025% gel alone

clindamycin phosphate 1.2%/tretinoin 0.025% gel plus benzoyl peroxide 6% foaming cloths DRUG

wash face with the benzoyl peroxide foaming cloth then rinse. then apply clindamycin phosphate 1.2%/tretinoin 0.025% gel. both done in the evening.

clindamycin / tretinoin gel plus benzoyl peroxide

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ≥ 12 years old.
• Subjects must be in good general health as confirmed by medical history and physical examination.
• Females of child-bearing potential must have a negative urine pregnancy test at the baseline visit and agree to use adequate birth control during the study (barrier, oral, injection, intrauterine or abstinence).
• Clear diagnosis of facial acne vulgaris for at least 3 months.
• Subject must have a static Physician's Global Assessment (PGA) of at least 2 (mild severity), but no more than 4.
• Disease must be stable or slowly worsening for more than one week prior to entering the study.
• Subjects or their guardians must be able to read, sign, and date the informed consent, and abide by study restrictions for its duration.

You may not qualify if:

• Females who are pregnant, attempting to conceive, or breastfeeding.
• Subjects with known hypersensitivity to study drug.
• Subjects with very severe acne (PGA score of 5)
• Subjects with overt signs of skin atrophy, telangiectasias or other skin findings that would affect efficacy evaluation.
• Subjects with a current active skin malignancy or infection.
• Subjects requiring the use of medications known to alter the course of acne vulgaris during the study treatment.
• Subjects who have received systemic antibiotics within 2 weeks.
• Subjects using systemic corticosteroids or immunosuppressants within 28 days of entering the study.
• Subjects who have received any topical therapies for acne vulgaris within 2 weeks of entering the study.
• Subjects taking birth control pills for less than 3 months or solely for the prevention of acne.
• Subjects who are currently participating in or, within the previous 28 days, have participated in another study for the treatment of acne vulgaris.
• Subjects with clinical conditions that may post a health risk to the subject by being involved in the study or detrimentally affect regular follow-up of the subject.

Sponsors & Collaborators

• Zeichner, Joshua, M.D.: lead

Study Sites (1)

Mt Sinai Hospital - Dept of Dermatology

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Acne Vulgaris

Interventions

clindamycin phosphate; Tretinoin; Gels; Benzoyl Peroxide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic

Central Study Contacts

Vicky Wong

CONTACT

212-241-3288

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Zeichner, Joshua, M.D.

Study Record Dates

• First Submitted: August 12, 2011
• First Posted: August 24, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2011
• Last Updated: August 24, 2011

Record last verified: 2011-08

Locations

US (1)