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A Multicenter, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Taro Pharmaceutical Inc.'s Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% to the Reference Listed Acanya® (Clindamycin Phosphate and Benzoyl Peroxide)Gel, 1.2%/2.5% and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris


Phase 3
12 Years
40 Years
Open (Enrolling)
Both
Acne Vulgaris

Thank you

Trial Information

A Multicenter, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Taro Pharmaceutical Inc.'s Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% to the Reference Listed Acanya® (Clindamycin Phosphate and Benzoyl Peroxide)Gel, 1.2%/2.5% and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris


Inclusion Criteria:



- Be willing and able to provide written informed consent/assent for the study.

- Be 12 to 40 years of age, inclusive. A subject may be of either sex and any
race/ethnicity.

- Have a clinical diagnosis of facial acne vulgaris with 25 or greater non-inflammatory
lesions and 20 or greater inflammatory lesions and no more than 2 nodulocystic
lesions.

- Have a baseline Investigator's Global Assessment of acne severity grade of 2, 3 or 4
on a severity scale of 0 to 4.

- Be willing and able to understand and comply with the requirements of the study,
apply the study medication as instructed, refrain from use of all other topical acne
medication and topical antibiotics during the 12-week treatment period, return for
the required treatment period visits, comply with therapy prohibitions, and able to
complete the study.

- Be in general good health and free from any clinically significant disease, other
than acne vulgaris, that might interfere with the study evaluations.

- Female subjects of childbearing potential must have a negative urine pregnancy test
amd must be willing to use a medically accepted method of contraception during the
study.

Exclusion Criteria:

- Presence of more than 2 facial nodulocystic lesions (i.e., nodules and cysts).

- Current diagnosis of acne conglobata, acne fulminans, or secondary acne.

- Presence of active cystic acne, or polycystic ovarian syndrome.

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

- Presence of any other facial skin condition that might interfere with acne vulgaris
diagnosis and/or assessment.

- Excessive facial hair that would interfere with diagnosis or assessment of acne
vulgaris.

- History of unresponsiveness to topical clindamycin phosphate and/or benzoyl peroxide
therapy.

- Start or change of dose of estrogens or hormonal treatment 3 months prior to baseline
or throughout the study.

- Use of medicated make-up throughout the study and significant change in the use of
consumer products within 30 days of study entry and throughout the study.

- Use of any of the following treatments more recently than the indicated washout
period prior to visit 1/day 1; need or intent to continue to use any of the following
treatments during the study: oral retinoids or therapeutic Vitamin A supplements of
greater than 10,000 units/day; systemic steroids; systemic antibiotics; systemic
treatment for acne vulgaris ; systemic anti-inflammatory or immunosuppressive agents
(NSAID use is allowed on an as-needed basis but for no more than 7 days of
consecutive use, low dose aspirin is allowed if on a stable dose for at least 30
days); Spironolactone; use on the face of cryodestruction or chemodestruction,
dermabrasion, photodynamic therapy, acne surgery, intralesional steroids, x-ray
therapy; topical retinoids; topical steroids; topical anti-acne medications; topical
anti-inflammatory agents; topical antibiotics; medicated cleansers; use of tanning
booths, sun lamps, sunbathing or excessive exposure to the sun; antipruritics,
including antihistamines.

- History of hypersensitivity or allergy to clindamycin phosphate, benzoyl peroxide,
and /or any ingredient in the study medication.

- Females who are pregnant, breastfeeding, intending to become pregnant during the
study, or who do not agree to use an acceptable form of birth control during the
study.

- Consumption of excessive alcohol, abuse of drugs, or a condition that could
compromise the subject's ability to comply with study requirements.

- Any clinically significant condition or situation other than acne vulgaris that would
interfere with the study evaluations or optimal participation.

- Use of any investigational drugs within 30 days prior to visit 1/day 1.

- Participation in any other clinical study in the 30 days prior to signing the
informed consent form.

- Previous participation in this study.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Mean percent change in inflammatory lesion counts.

Outcome Description:

Mean percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts.

Outcome Time Frame:

12 weeks

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

CLBG 1210

NCT ID:

NCT01769235

Start Date:

November 2012

Completion Date:

December 2013

Related Keywords:

  • Acne Vulgaris
  • Acne Vulgaris
  • Clindamycin Phosphate and Benzoyl Peroxide Gel
  • Acanya® Gel
  • Acne Vulgaris

Name

Location

Research Across AmericaCarrollton, Texas  75010
Clinical Research Associates, Inc.Nashville, Tennessee  37203
Longmont Clinic PCLongmont, Colorado  80501
Minnesota Clinical Study CenterFridley, Minnesota  55432
T. Joseph Raoof, MD, Inc.Encino, California  91436
Dawes Fretzin Clinical Research Group, LLCIndianapolis, Indiana  46256
Omega Medical ResearchWarwick, Rhode Island  02886
DermResearch, Inc.Austin, Texas  78759
Altman Dermatology AssociatesArlington Heights, Illinois  60004
Clinical Research Associates of TidewaterNorfolk, Virginia  23507
Progressive Clinical ResearchSan Antonio, Texas  78229
Dermatology Consulting ServicesHigh Point, North Carolina  
Clinical Science InstituteSanta Monica, California  90404
Meridien ResearchBradenton, Florida  34208
Coastal Clinical Research, Inc.Mobile, Alabama  36608
MedDerm AssociatesSan Diego, California  92103
Northeast Dermatology AssociatesBeverly, Massachusetts  01915
Walter K. Nahm MD, PhD, Inc.San Diego, California  92123
Redwood DermatologySanta Rosa, California  95403
The Center for Clinical and Cosmetic ResearchAventura, Florida  33180
DBA Advanced Dermatologic Care and Cancer CenterDelray Beach, Florida  33444
Tory Sullivan, MD, PAN. Miami Beach, Florida  33162
South Bend Clinic, LLPSouth Bend, Indiana  46617
Callender Center for Clinical Research, LLCGlenn Dale, Maryland  20769
Fordham DermatologyBronx, New York  10458
Pinkas E. Lebovits, MD, PCNew York, New York  10019
Charlotte Skin and LaserCharlotte, North Carolina  28207
J&S Studies, Inc.College Station, Texas  77845
Reliance Clinical Testing Services, Inc.Irving, Texas  75062