Evaluation of combination of Benzoyl peroxide, Zinc oxide and Polysiloxanes on incidence of acne scars.
- Conditions
- Health Condition 1: null- Acne Vulgaris
- Registration Number
- CTRI/2017/09/009855
- Lead Sponsor
- Dr Reddys Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
1. Males and females of 12 â?? 45 years (both inclusive).
2. Subjects with facial acne inflammatory lesion (Papules and Pustules) count no less than 30 but no more than 60.
3. Subjects with facial acne non-inflammatory lesion (open andclosed comedones) count no less than 40 but no more than 100.
4. Subject must have an Acne IGA Score (Investigator Global Assessment score) of moderate grade (3).
5. Subjects with not more than one nodule for moderate acne vulgaris (defined as an inflammatory lesion >= 5 mm in diameter).
6. Females of child-bearing potential should have a negative urine pregnancy test prior to beginning therapy and agree to use
adequate birth control during the study (acceptable methods include hormonal contraception maintained for a period of 3
months prior to the study and persisting through the study period, intrauterine device, barrier or abstinence).
7. Subjects willing to provide written informed consent (subject < 18 years of age, willing to provide an assent for the study and
Parent/Legal guardian shall provide written informed consent) and comply with study instructions for its duration.
1. Subjects with history of hypersensitivity or allergic reactions to any of the study preparations.
2. Subjects who are concomitantly using any potentially irritating over-the-counter products that contained ingredientsâ?? such as 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 moustache 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 history of regional enteritis, ulcerative colitis, or antibiotic associated colitis.
11. Subjects who are receiving treatment for any type of cancer within last six months.
12. Subjects with clinically significant cardiovascular, endocrine, liver, lung, neurologic, renal or psychiatric disorder.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects with incidence of acne scarring (new scars) at week 24 between two groups.Timepoint: Proportion of subjects with incidence of acne scarring (new scars) at week 24 between two groups.
- Secondary Outcome Measures
Name Time Method Objective assessment of Physician scores of improvement as <br/ ><br>determined by global acne scarring classification of Goodman & Baron at week 24.Timepoint: Baseline to Week 24;Photographic evaluation of acne scars by Goodman and Baronâ??s qualitative grading system from baseline to week 24.Timepoint: Baseline to Week 24;Local tolerance assessment by Investigator (Erythema, Scaling) and <br/ ><br>by Subject (Itching, Burning and Stinging) from baseline to week 2, 4, 8, 12 and week 16Timepoint: Baseline to week 2, <br/ ><br>4, 8, 12 and week 16;Mean Percentage change in Total facial acne lesion counts <br/ ><br>(inflammatory and non-inflammatory) from baseline to week 16Timepoint: Baseline to Week 16;The percentage of subjects who are clear or almost clear at week 16 <br/ ><br>in an Acne IGA Score (Investigator Global Assessment Score)Timepoint: Baseline to Week 16