NCT06252194

Brief Summary

The goal of this clinical trial is to compare the effect of doxycycline and metformin in treatment of acne vulgaris patients. The main question is aimed to answer is whether metformin is more effective than doxycycline in treatment of acne vulgaris patient or not. Patients will be asked to take doxycycline along with tropical treatment in one group and metformin along with tropical treatment in another group. Researcher will compare the clinical improvement in two groups.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 9, 2024

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

12 months

First QC Date

January 30, 2024

Last Update Submit

February 7, 2024

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

  • Global Acne Grading System (GAGS) Score

    Acne Vulgaris Severity assesment by GAGS score

    12 weeks

Study Arms (2)

Group A

EXPERIMENTAL

Metformin 500 mg twice daily along with topical retinoids for 12 weeks

Drug: Metformin and doxycycline

Group B

ACTIVE COMPARATOR

Doxycycline 100 mg twice daily along with topical retinoids for 12 weeks

Drug: Metformin and doxycycline

Interventions

Metformin and doxycyclineDRUG

Metformin 500 mg tablet twice daily

Group AGroup B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed moderate and severe AV patients diagnosed by a dermatologist

You may not qualify if:

  • Patients receiving topical retinoids within last two months
  • Pregnancy and lactation
  • History of corticosteroids intake
  • Suffering from malignancy or any cosmetic induced acne

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BSMMU

Dhaka, Bangladesh

RECRUITING

MeSH Terms

Conditions

Acne Vulgaris

Interventions

MetforminDoxycycline

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Central Study Contacts

Muhammad Marnush, MBBS

CONTACT

88001714558447marnushm@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 30, 2024

First Posted

February 9, 2024

Study Start

March 5, 2023

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

February 9, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

BA(1)