se of metformin in non hormonal acne in addidition to doxycycline:New regime
Phase 1
Completed
- Conditions
- Health Condition 1: null- Acne
- Registration Number
- CTRI/2017/12/010963
- Lead Sponsor
- Gauhati medical college
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
moderate or severe acne vulgaris as defined by the Investigatorâ??s Global Assessment (IGA; score of 3 or
4).
Exclusion Criteria
Patients with any clinical evidence of hormonal
dysfunction, metabolic syndrome, insulin resistance, hypertension, diabetes mellitus, and
PCOS will be excluded by appropriate testing methods.
Patients with acne conglobata, acne
fulminans or other dermatological pathologies over face which could interfere with treatment or evaluation to be excluded.
Patients on isotretinoin excluded and for any other medication(topical/oral) a period of 4 weeks abstinence
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the efficacy and safety of oral metformin by evaluating the total reduction in inflammatory and non inflammatory acne,patient satisfaction.Timepoint: The efficacy and safety of oral metformin will be assessed after 12 weeks from the starting point.(biweekly follow up will be done)
- Secondary Outcome Measures
Name Time Method To compare the efficacy and safety of oral metformin, doxycycline (for initial 1 month only) and topical BPO, once daily each for 4 weeks followed by twice daily metformin and BPO OD for 8 weeks; with doxycycline (for initial 1 month only), matched <br/ ><br>161 placebo and topical BPO, once daily each for 4 weeks and later placebo BID and BPO OD for 8 weeks; in the treatment of moderate-severe facial acne.Timepoint: To compare the efficacy and safety of oral metformin, doxycycline (for initial 1 month only) and topical BPO, once daily each for 4 weeks followed by twice daily metformin and BPO OD for 8 weeks; with doxycycline (for initial 1 month only), matched <br/ ><br>161 placebo and topical BPO, once daily each for 4 weeks and later placebo BID and BPO OD for 8 weeks; in the treatment of moderate-severe facial acne.