Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 25 of 233 for:    acne AND Percent

Double-blind Placebo-controlled Trial of Generic Clindamycin/Benzoyl Peroxide Gel Versus Onexton Gel in Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02616614
Recruitment Status : Completed
First Posted : November 30, 2015
Last Update Posted : November 30, 2015
Sponsor:
Information provided by (Responsible Party):
Actavis Inc.

Brief Summary:
Actavis has developed a generic formulation of clindamycin 1.2% and benzoyl peroxide 3.75% gel. This study is designed to evaluate the safety and efficacy of this formulation in subjects with Acne Vulgaris

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Onexton Drug: Clindamycin/benzoyl peroxide gel Drug: Placebo Phase 3

Detailed Description:

This is a randomized, double blind, three-arm, parallel group, placebo control bioequivalence study with clinical endpoint, at multiple study sites, designed to establish bioequivalence of clindamycin 1.2% and benzoyl peroxide 3.75% gel of Actavis and Onexton® (clindamycin 1.2% and benzoyl peroxide 3.75%) gel in the treatment of subjects with Acne Vulgaris.

The primary objective is to evaluate the bioequivalence of a generic of clindamycin 1.2% and benzoyl peroxide 3.75% gel to Onexton® in the treatment of subjects with acne vulgaris.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 818 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate the Bioequivalence of a Generic Clindamycin 1.2% and Benzoyl Peroxide 3.75% Gel to Onexton® Gel in Subjects With Acne Vulgaris
Study Start Date : May 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : November 2015


Arm Intervention/treatment
Active Comparator: Onexton gel
Clindamycin 1.2% and benzoyl peroxide 3.75% topical gel Applied a thin film of medication onto 6 areas of the face (chin, left cheek, right cheek, nose, left forehead, and right forehead) once daily
Drug: Onexton
Topical gel for treating acne
Other Name: Clindamycin/benzoyl peroxide gel

Experimental: Clindamycin/benzoyl peroxide gel
Generic clindamycin 1.2% and benzoyl peroxide 3.75% topical gel. Applied a thin film of medication onto 6 areas of the face (chin, left cheek, right cheek, nose, left forehead, and right forehead) once daily
Drug: Clindamycin/benzoyl peroxide gel
Generic Clindamycin/benzoyl peroxide gel for treating acne
Other Names:
  • Clindamcyin Phosphate
  • BPO

Placebo Comparator: Placebo
A vehicle gel. Applied a thin film of medication onto 6 areas of the face (chin, left cheek, right cheek, nose, left forehead, and right forehead) once daily
Drug: Placebo
Vehicle gel used as a placebo
Other Name: Vehicle




Primary Outcome Measures :
  1. Percent change in the inflammatory (papules and pustules) lesion counts [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. The proportion of subjects with an IGA that is at least 2 grades less than the baseline assessment [ Time Frame: 12 weeks ]
  2. Percent change in the non-inflammatory (open and closed comedones) [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris
  • On the face, ≥25 non-inflammatory lesions (i.e., open and closed comedones) and ≥ 20 inflammatory lesions (i.e., papules and pustules) and ≤ 2 nodulocystic lesions (i.e., nodules and cysts). For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area. Counts of nodules and cysts should be reported separately and not included in the inflammatory or non-inflammatory lesion counts. Lesions involving the eyes and scalp should be excluded from the count. (Subjects may have acne lesions on other areas of the body (e.g., on the back)).
  • Subjects must have Investigator's Global Assessment (IGA) of acne severity grade 2, 3, or 4.
  • Willing to refrain from use of all other topical acne medications or antibiotics during the 12 week treatment period. Subjects may use other topical acne treatments that do not have significant or measurable systemic absorption for treatment of acne of the back, shoulders and chest (e.g. benzoyl peroxide, salicylic acid).
  • Subjects who are 18 years of age or older must have provided Institutional Review Board (IRB) approved written informed consent. Subjects who are at least 12 years of age and less than 18 years of age must have provided IRB approved written assent; this written assent must be accompanied by an IRB approved written informed consent from the subject's legally acceptable representative (i.e., parent or guardian). In addition, all subjects or their legally acceptable representatives (i.e., parent or guardian) must sign a Health Insurance Portability and Accountability Act (HIPAA) authorization, if applicable.
  • Male subjects and Female subjects of childbearing potential must use accepted methods of birth control or must agree to practice abstinence, from study start to 30 days after the last administration of study drug. All female subjects are considered to be of childbearing potential unless they have been surgically sterilized or have been postmenopausal for at least 1 year. Any of the following methods of birth control are acceptable: oral contraceptives, contraceptive patches/implants (e.g., Norplant®), vaginal ring (NuvaRing®), Depo-Provera® (Medroxy progesterone acetate), double barrier methods (e.g., condom and spermicide) or intrauterine device (IUD).
  • Female subjects of child bearing potential must have a negative urine pregnancy test at baseline.
  • Subjects who use make-up 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 not change make-up brand/type or frequency of use throughout the study.

Exclusion Criteria:

  • History of hypersensitivity or allergy to clindamycin or benzoyl peroxide and/or any of the study medication ingredients or lincomycin or any other allowed product used during the study.
  • Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
  • Excessive facial hair (beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris. Patient is allowed to shave the excessive facial hair at least a day before visiting the site for study assessments.
  • Use within 6 months prior to baseline of oral retinoids (e.g. Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day.
  • Use for less than 3 months prior to baseline of estrogens or oral contraceptives; use of such therapy must remain constant throughout the study.
  • Use on the face within 1 month prior to baseline or during the study of: 1) cryodestruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, or 6) x-ray therapy.
  • Use within 1 month prior to baseline of: 1) spironolactone, 2) systemic steroids, 3) systemic antibiotics, 4) systemic treatment for acne vulgaris or 5) systemic anti-inflammatory agents.
  • Use within 2 weeks prior to baseline of: 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti- inflammatory agents, 5) medicated cleansers or 6) topical antibiotics.
  • Subjects who have acne fulminans, and secondary acne (e.g., chloracne and drug induced acne) will be excluded from participation.
  • Female subjects who are pregnant, nursing or planning to become pregnant during study participation (Visit 1 through Visit 4 and 30 days post visit 4) will be excluded from study participation.
  • Subjects who have received radiation therapy and/or anti-neoplastic agents within 90 days prior to baseline will be excluded from study participation.
  • Subjects who have unstable medical disorders that are clinically significant or life-threatening diseases will be excluded from study participation.
  • Subjects who have on-going malignancies requiring systemic treatment will be excluded from study participation. In addition, subjects who have any malignancy of the skin of the facial area will be excluded from study participation.
  • Subjects who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold, will be excluded from study participation.
  • Subjects who have facial sunburn will be excluded from study participation
  • Subjects who consume excessive amounts of alcohol (greater than two drinks per day) or use drugs of abuse (including, but not limited to, cannabinoids and cocaine) as judged by their medical history will be excluded from study participation.
  • History or presence of significant smoking (more than 10 cigarettes or any other form of tobacco smoking/day or consumption of tobacco products).
  • Systolic blood pressure less than 90 mm Hg or more than 140 mm Hg, Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg and Pulse rate less than 50 beats/minute or more than 100 beats/minute.
  • Subjects who have participated in an investigational drug study (i.e., subjects have been treated with an investigational drug) within 1 month prior to baseline will be excluded from study participation. Subjects who are participating in non- treatment studies such as observational studies or registry studies can be considered for inclusion.
  • Major illness, as per investigator's discretion, during 3 months before screening.
  • Subjects who have been previously enrolled in this study will be excluded from study participation.
  • Subjects who have had laser therapy and electrodesiccation to the facial area within 180 days prior to study entry will be excluded from participation.
  • Subjects who have had cosmetic procedures (e.g., facials) which may affect the efficacy and safety profile of the investigational product within 14 days prior to study entry will be excluded from participation.
  • Subjects who have had general anesthesia for any reason and subjects who have received neuromuscular blocking agents within 14 days prior to study entry will be excluded from study participation.
  • Subjects who have a baseline score of 3 (severe, marked/intense) as per the Application Site Reaction Scale (Section 5.2) will be excluded from participation.
  • Any employees or staff of the research site are excluded from study participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02616614


Locations
Layout table for location information
United States, Arizona
Alliance Dermatology
Phoenix, Arizona, United States, 85032
United States, California
Estudy
Chula Vista, California, United States, 91911
Estudy
La Mesa, California, United States, 91942
United States, Florida
Tampa Bay Medical Research
Clearwater, Florida, United States, 33761
AMB Research Center
Miami, Florida, United States, 33144
United States, Georgia
Meridian Clinical Research
Savannah, Georgia, United States, 31406
United States, Kansas
Heartland Research Assoc
Augusta, Kansas, United States, 67010
Heartland Research Assoc
Wichita, Kansas, United States, 67207
United States, Missouri
Sundance Clinical Research
St. Louis, Missouri, United States, 63141
United States, Nebraska
Meridian Clinical Research
Norfolk, Nebraska, United States, 68701
Meridian Clinical Research
Omaha, Nebraska, United States, 68134
United States, North Carolina
Dermatology Consulting Services
High Point, North Carolina, United States, 27262
United States, Ohio
Sterling Research Group
Cincinnati, Ohio, United States, 45246
United States, Texas
Discover Research
Beaumont, Texas, United States, 77701
DiscoverResearch Inc
Bryan, Texas, United States, 77802
Reseacr Across America
Dallas, Texas, United States, 75234
United States, Virginia
Clinical Research Assoc. of Tidewater
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Actavis Inc.
Investigators
Layout table for investigator information
Study Director: Henry lau, PhD Actavis Inc.

Layout table for additonal information
Responsible Party: Actavis Inc.
ClinicalTrials.gov Identifier: NCT02616614     History of Changes
Other Study ID Numbers: WAT/CMBP/2015
First Posted: November 30, 2015    Key Record Dates
Last Update Posted: November 30, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Layout table for MeSH terms
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Benzoyl Peroxide
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents