CTRI/2020/05/025476OtherPhase 3
A Randomized, Double Blind, Multicentric, Parallel-group, Phase III Clinical Trial to evaluate the Efficacy & Safety of 5% Spironolactone Topical Cream versus Placebo in Patients with Acne Vulgaris.
Alkem Laboratories Limited0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Other
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. Subject provides written informed consent
- •2. Subject has an IGA score 3 or 4
- •3. On the face ââ?°Â¥ 20 non-inflammatory lesions (Open and closed comedones) and ââ?°Â¥ 10 non-inflammatory lesions (papules and pustules) and ââ?°Â¤ 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
- •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/
Investigators
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