Health Condition 1: L700- Acne vulgaris
Conditions
Interventions
Intervention1: 5% topical spironolactone: 5% topical spironolactone
Twice a Day Application (at least 12 hours apart) for 12 weeks
Intervention2: 5% topical spironolactone: 5% topical spironolactone
Twice a Day Application (at least 12 hours apart) for 12 weeks
Control Intervention1: Placebo: Placebo
Topical cream for twice a day application (at least 12 hours apart) for 12 weeks
Sponsors
Alkem Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 b. Platelet Count c. Total bilirubin level >1.5 times the upper limit of normal ULN d. Hemoglobin 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/L
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the safety and tolerability of the Investigational product 2. To evaluate the pharmacokinetics of 5% Spironolactone Topical CreamTimepoint: 1. All patient completing till week 12 2. pK assessment: Week 0, 4, 8 and 12 | — |
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of 5% Spironolactone Topical Cream versus placebo in patients with Acne vulgarisTimepoint: All patient completing till week 12 | — |
Countries
India
Contacts
Public ContactDr Vinayaka Shahavi
Alkem Laboratoroes Limited
Outcome results
None listed