A Phase 3 clinical study to Evaluate the Efficacy and Safety of Tretinoin (Microsphere) 0.04% and Clindamycin 1% Combination Gel in Comparison to Tretinoin 0.025% Gel and Clindamycin 1% Gel in the treatment of patients with Acne (Pimples)
- Conditions
- Health Condition 1: null- Acne Vulgaris
- Registration Number
- CTRI/2014/08/004830
- Lead Sponsor
- Dr Reddys Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 750
1.Males and females more than or equalto 12 years old.
2.Subjects with facial acne inflammatory lesion (Papules and Pustules) count no less than twenty but no more than fifty.
3.Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no less than twenty but no more than hundred.
4.Subjects with two or fewer nodules (defined as an inflammatory lesion more than or equal to five mm in diameter)
5.Subject must have an ISGA Score(Investigatorâ??s static global assessment score) of moderate (equalto 3) or severe (equalto 4).
6.Females of child-bearing potential and sexually active must have a negative urine pregnancy test at the baseline visit and agree to use adequate birth control during the study (acceptable methods include hormonal contraception maintained for a period of three months prior to the study and persisting through the study period, intrauterine device, barrier or abstinence).
7.Subjects willing to provide written informed consent and agree for audio/video recording of consent process (subject less than eighteen years of age, were to sign an assent for the study and Parent or Legal guardian shall sign the informed consent form) and comply with study instructions for its duration.
1.Subjects with an history of hypersensitivity or allergic reactions to any of the study preparations as described in the investigators brochure, including known sensitivities to any dosage form of clindamycin, lincomycin, or Tretinoin;
2.Subjects who are concomitantly using any potentially irritating over-the-counter products that contained ingredientsâ?? such as benzoyl peroxide, alpha-hydroxy acids, salicylic acid, retinol or glycolic acids;
3.Subjects not willing to undergo the specified washout periods for the following topical preparations, or required the concurrent use of any of the following topical medication:
•Antibiotics on the facial area(2 weeks) Other topical anti-acne drugs (2 weeks)
•Anti-inflammatory agents and corticosteroids on the facial area (4 weeks)
•Retinoids, including retinol (4 weeks)
4.Subjects not willing to undergo the specified washout periods for the following systemic medication, or required the concurrent use of any of the following systemic medication:
•Corticosteroids (including intramuscular injections) (4 weeks)
•Antibiotics (4 weeks) other systemic acne treatments (4 weeks)
•Systemic retinoids (6 months)
5.Subjects who have participated in a clinical drug or device research study, 30 days prior to the enrollment or are participating in a research study, concurrent with this study;
6.Subjects who have dermatological conditions on the face such as acne conglobata, acne fulminans, secondary acne, etc, that could interfere with clinical evaluations;
7.Subjects who have any underlying disease or other dermatological condition of the face that required the use of interfering topical or systemic therapy.
8.Subjects with facial beard or mustache that could interfere with the study assessments;
9.Females who are pregnant, breast feeding, or planning a pregnancy during the proposed study period.
10.Subjects with an history of regional enteritis, ulcerative colitis, or antibiotic associated colitis;
11.Subjects who are receiving treatment of any type for cancer within last six months;
12.Subjects with clinically significant cardiovascular, liver, lung, neurologic, renal or psychiatric disorder, or clinically significant laboratory abnormalities (if laboratory values exceed the threshold limits set out for this study, the approval of Medical Monitor should be taken into consideration before randomizing the subject).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean Percent change from baseline to week 12 in <br/ ><br>-Inflammatory lesion counts <br/ ><br>-Non-inflammatory lesion counts <br/ ><br>-Total lesion counts <br/ ><br>Timepoint: Baseline and Week 12
- Secondary Outcome Measures
Name Time Method The percentage of subjects who are clear or almost clear at week 12 or had 2 grades of improvement from baseline to week 12 in an ISGA Score (Investigatorâ??s static global assessment Score).Timepoint: Baseline and week 12