Comparison of 5% Spironolactone Topical Cream with Placebo for safety and efficacy in Patients with Acne Vulgaris
- Conditions
- Health Condition 1: L700- Acne vulgaris
- Registration Number
- CTRI/2020/05/025476
- Lead Sponsor
- Alkem Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 0
1. Subject provides written informed consent
2. Subject has an IGA score 3 or 4
3. On the face � 20 non-inflammatory lesions (Open and closed comedones) and � 10 non-inflammatory lesions (papules and pustules) and � 2 nodular lesions
4. Willing to refrain from use of prohibited medications during the 12-week treatment period.
5. Subject is willing to comply with study instructions and visits.
6. Have used the same brand of make-up for a minimum period of 2 weeks prior to randomization, for subject who use make-up, and agree to not change make-up brands or types during the study.
1. Subject is pregnant, lactating, or is planning to become pregnant during the study
2. Known hypersensitivity to spironolactone or any component of the investigational product.
3. Subject with nodulocystic acne.
4. Subject with skin condition that could interfere with assessment of acne vulgaris or requires the use of interfering topical or systemic therapy
5. subject currently enrolled in any trial or has been treated with an investigational device within 30 days prior to the initiation of treatment
6. Subject with excessive facial hair especially full-grown beard, mustaches that could interfere with the study assessment
7. Subject is unable to communicate with the investigator due to language problem or poor mental development or impaired cerebral function.
8. Subject involve in excessive alcohol intake or drug abuse or unable to comply with scheduled visits
9. Subject using any other acne treatment within 4 weeks of randomization
10. Subject using estrogen or oral contraceptives within 4 weeks prior to randomization.
11. Subject who have used oral or topical corticosteroids or oral immunosuppressive drugs within 4 weeks prior to randomization
12. Patient having the following laboratory results at screening:
a. ANC < 1,500/mm3
b. Platelet Count < 100,000/mm3
c. Total bilirubin level >1.5 times the upper limit of normal ULN
d. Hemoglobin < 10 g/dL
e. AST and ALT more than equal to 3.0 x ULN
f. Alkaline Phosphate more than equal to 3.0 x ULN
g. Serum Creatinine level > 1.25 xULN
h. Serum potassium >5.0 mEq/
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method