Use of metformin in non hormonal acne in addidition to doxycycline:New regimen

Redefining the role of metformin in non-hormonal acne: A single-blind randomized placebo controlled interventional study comparing the efficacy of oral metformin and topical BPO vs. placebo and topical BPO; with initial 1 month of doxycycline, in the treatment of moderate-severe facial acne. - ACME

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/12/010963

Enrollment

Registered

2017-12-22

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Acne

Interventions

Intervention1: Metformin: Patients fulfilling the inclusion criterias will be matched and randomised int two groups: Group A: will recieve metformin 500mg once daily together with doxycycline 100mg o

Eligibility

Inclusion criteria

Inclusion criteria: moderate or severe acne vulgaris as defined by the Investigatorâ??s Global Assessment (IGA; score of 3 or 4).

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 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 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.	—

Measure

Time frame

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 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 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.

—

Countries

India

Contacts

Public ContactMehak Singh

Gauhati Medical College and Hospital

med.mehak@gmail.com9406565269

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026