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Evaluate Therapeutic Equivalence and Safety of Two Clindamycin Phosphate and Benzoyl Peroxide Gels in Acne Vulgaris

Information source: Watson Laboratories, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acne Vulgaris

Intervention: Clindamycin Phosphate / Benzoyl Peroxide Gel (Drug); Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% (Drug); Placebo (Vehicle Gel) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Watson Laboratories, Inc.

Official(s) and/or principal investigator(s):
John L Capicchioni, Study Director, Affiliation: Akesis, LLC

Summary

Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel, 1. 2%/2. 5% gel marketed by Valeant Pharmaceuticals, North America, is a safe and effective topical therapy used for the treatment of acne vulgaris.

Clinical Details

Official title: A Multicenter, Double-blind, Randomized, Vehicle-controlled, Parallel-group Study Comparing Clindamycin Phosphate and Benzoyl Peroxide Gel and Acanya® 1.2%/2.5% and Both Active Treatments to Vehicle Control for Treating Acne Vulgaris

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The evaluation of the primary endpoint will be based on the mean percent changes from baseline to week 12 in the inflammatory (papules and pustules) lesion counts and in the non-inflammatory (comedones) lesion counts.

Secondary outcome: The proportion of subjects with a clinical response of "success" at Week 12 using IGA.

Detailed description: Watson Laboratories, Inc. has developed a generic formulation of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1. 2%/2. 5%,and the current study is designed to evaluate the safety and efficacy of this formulation to determine if it is bioequivalent to Acanya.

Eligibility

Minimum age: 12 Years. Maximum age: 40 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy male or non pregnant female

- ≥ 12 and ≤ 40 years

- Diagnosis of acne vulgaris (acne)

- >18 years and provide written informed consent

- Ages 12 to 17 and provide written assent and written informed consent from patient's

legal representative

- Must sign a HIPAA authorization

- Minimum ≥ 25 non-inflammatory lesions

- ≥ 20 inflammatory lesions

- ≤ 2 nodulocystic lesions on the face

- Acne of severity grade 2, 3, or 4 -Investigator's Global Assessment (IGA)

- Refrain from all other topical acne medications or antibiotics during the 12-week

treatment period except Investigational Product

- All Female patients with a negative urine pregnancy test who use birth control from

the study start to 30 days after the last administration of study drug

- All male patients who use birth control with their partners, from the study start to

30 days after the last administration of study drug. Abstinence is acceptable. Female partners should use birth control

- Must be willing and able to understand and comply with the protocol requirements and

required study visits

- In good health

- Free from any clinically significant disease

- Must have used the same brands/types of make-up for a minimum period of 14 days prior

to study entry and must agree to use the same make-up, brand/type and maintain the same frequency of use throughout the study Exclusion Criteria:

- Female patients who are pregnant, nursing or planning to become pregnant during study

- History or presence of Crohn's disease, ulcerative colitis, regional enteritis, or

antibiotic-associated colitis

- Hypersensitivity or allergy to benzoyl peroxide, clindamycin and/or any of the study

medication ingredients

- Presence of any skin condition that would interfere with the diagnosis or assessment

- Excessive facial hair

- Wax epilation of the face within 14 days prior

- Used oral retinoids or therapeutic vitamin A supplements of >10,000 units/day

(multivitamins are allowed) within 6 months prior to or during the study

- Estrogens or oral contraceptives for <3 months prior to baseline; Use of such therapy

must remain constant throughout the study

- Cryodestruction, chemodestruction, dermabrasion, photodynamic therapy, acne surgery,

intralesional steroids, X-ray therapy procedures performed on the face within 1 month prior to or during the study

- Any systemic (steroids, antibiotics treatment for acne, anti-inflammatory agents)

treatments within 1 month prior to baseline or during the study

- Any (topical steroids, topical retinoids, α-hydroxy/glycolic acid, benzoyl peroxide,

topical anti-inflammatory agents, topical antibiotics) treatments within 2 weeks prior to baseline or during the study:

- Intend to use Spironolactone

- Intend to use tanning booths, sunbathing, or excessive exposure to the sun

- Radiation therapy and/or anti-neoplastic agents within 90 days prior to baseline

- Unstable clinically significant medical disorders or life-threatening diseases

- On-going malignancies requiring systemic treatment

- Any malignancy of the facial area skin

- Engage in activities that involve excessive or prolonged exposure to sunlight or

weather extremes

- Consume excessive amounts of alcohol or use drugs of abuse

- Participation in an investigational drug study within 30 days prior

- Are participating in non-treatment studies such as observational studies or registry

studies can be considered for inclusion

- Previously enrolled in this study

- Laser therapy, electrodessication and phototherapy to the facial area within 180 days

prior to study entry

- Cosmetic procedures which may affect the efficacy and safety profile of the study

drug within 14 days prior to study entry

- Currently have or have recently had bacterial folliculitis on the face

Locations and Contacts

Additional Information

Starting date: July 2012
Last updated: February 7, 2013

Page last updated: August 23, 2015

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