To evaluate action and saety of test product Benzoyl peroxide and Clindamycin Phosphate gel with Reference Product BenzaClin Topical gel in treatment of patients with medium to high acne vulgaris.
- Conditions
- Health Condition 1: null- Mild to severe acne vulgaris
- Registration Number
- CTRI/2017/09/009884
- Lead Sponsor
- Alvogen Pine Brook LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Healthy male or non-pregnant female aged greater than or equal to 12 and less than or equal to 40 years with a clinical diagnosis of acne vulgaris.
2. Patients who are 18 years of age or older (up to the age of 40) must have provided Institutional Review Board (IRB)/ Independent Ethics committee (IEC) approved written informed consent. Patients 12 to 17 years of age inclusive must have provided IRB/IEC approved written assent; this written assent must be accompanied by an IRB/IEC approved written informed consent from the patientâ??s legally acceptable representative (i.e., parent or guardian). In addition, all patients or their legally acceptable representatives (i.e., parent or guardian) must sign a HIPAA authorization if
applicable.
3. Patients must have greater than or equal to 25 non-inflammatory lesions (i.e., open and closed comedones)AND greater than or equal to 20 inflammatory lesions (i.e., papules and pustules) AND less than or equal to 2 nodulocystic lesions (i.e., nodules and cysts), at baseline on the face. This includes lesions on the nose, but not those involving the eyes, lips, scalp, back, chest or arm.
4. Patients must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigatorâ??s Global Assessment(IGA) scale.
5. Patients must be willing to refrain from using all other topical acne medications or
antibiotics during the 10-week treatment period, other than the Investigational Product.
6. Female patients of childbearing potential (excluding women who are surgically sterilized or postmenopausal for at least 1 year), in addition to having a negative urine pregnancy test, must be willing to use an acceptable form of birth control during the study from the day of the first dose administration to 30 days after the last administration of study drug.
Note: For the purpose of this study the following are considered acceptable methods of birth control: oral or injectable contraceptives, contraceptive patches, Depo-Provera® (stabilized for at least 3 months) NuvaRing® (vaginal contraceptive); Implanon• (contraceptive implant) double barrier methods (e.g. condom and spermicide or diaphragm with spermicide), IUD, or abstinence with a 2nd acceptable method of birth control should the patient become sexually active. A sterile sexual partner is NOT considered an adequate form of birth control. Tubal ligation is not considered equivalent to female sterilization (i.e., hysterectomy). Women with a history of tubal ligation are still considered females of childbearing potential and must use birth control, as noted above.
1. Female patients who are pregnant, nursing or planning to become pregnant during study
participation.
2. Patients with a history of hypersensitivity or allergy to benzoyl peroxide, clindamycin,
retinoids, lincomycin and/or any of the study medication ingredients.
3. Patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.
4. Patients with the 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, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
5. Patients with excessive facial hair (e.g. beards, sideburns, mustaches, etc.) that would
interfere with diagnosis or assessment of acne vulgaris.
6. Patients who have performed wax depilation of the face within 14 days prior to Baseline.
7. Patients who have used within 6 months prior to Baseline or use during the study of oral retinoids (e.g. Accutane®) or therapeutic Vitamin A supplements of greater than 10,000 units/day.
Note: Multivitamins are allowed.
8. Patients who have used estrogens or oral contraceptives for less than 3 months prior to
Baseline; use of such therapy must remain constant throughout the study.
9. Patients who have used any of the following procedures on the face within 1 month prior to Baseline or use during the study:
a. cryodestruction or chemodestruction,
b. dermabrasion/micro dermabrasion,
c. photodynamic therapy,
d. acne surgery,
e. intralesional steroids, or
f. X-ray therapy
10. Patients who have used any of the following treatments within 1 month prior to Baseline or during the study:
a. spironolactone,
b. systemic steroids,
c. systemic antibiotics,
d. systemic treatment for acne vulgaris (other than oral retinoids, which require a 6- month washout), or
e. systemic anti-inflammatory agents. If the patient uses a systemic anti-inflammatory
product during the study, the Principal Investigator will judge if this protocol
violation is clinically significant.
11. Patients who have used any of the following treatments within 2 weeks prior to Baseline or during the study:
a. topical steroids,
b. topical retinoids,
c. topical acne treatments including over-the-counter preparations
d. topical anti-inflammatory agents,
e. medicated cleansers, or
f. topical antibiotics.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary efficacy measures are: <br/ ><br>1.mean percent change from baseline to week 10 ([day 70]) in the inflammatory lesion count (papules and pustules) lesion count, and in the noninflammatory (open and closed comedones) lesion count. <br/ ><br>Note: when counting facial acne lesions, it is important that all lesions be counted, including those present on the nose. Counts of nodules and cysts should be reported separately and should not be included in the inflammatory or non-inflammatory lesion counts.Timepoint: The time point measurements are as follows: Day 0, Day 28±4 days, Day 56±4 days, Day 70±4 days.The test product and the reference product should be statistically superior to placebo (p0.05) with regard to percent change from baseline to week 10 in inflammatory <br/ ><br>lesion counts using the mITT study population and the last observation carried <br/ ><br>forward (LOCF).
- Secondary Outcome Measures
Name Time Method The dichotomized IGA severity scale will be used as a secondary endpoint for supportive evidence, to determine the proportion of patients with a clinical response of â??successâ?? at week 10 (day 70).Timepoint: The time point measurements are as follows: Day 0, Day 28±4 days, Day 56±4 days, Day 70±4 days. Success will be defined as an IGA score that is at least 2 grades less than the baseline <br/ ><br>assessment. <br/ ><br>Failure will be defined as an IGA score that is same, higher or one grade lower than the <br/ ><br>baseline assessment.