Vitamin A and Azithromycin for Acne Vulgaris

Early Phase 1

• Conditions: Acne Vulgaris
• Interventions: Drug: Vitamin A; Drug: Azithromycin

• Registration Number: NCT03090048
• Lead Sponsor: Manchanda Medical Clinic

Brief Summary

Patients seen with acne lesions not having responded to existing treatments will be offered a placebo or a topical preparation consisting of Vitamin A USP with or without Azithromycin for a duration of 4-6 months USP for the objective of resolving the lesions without systemic side effects and via weekly follow-ups.

Detailed Description

The concentrations of the active ingredients is based on the enclosed articles and the formulations have been modified with an objective of minimizing the side effects.

Study Timeline

• Study First Submitted: 2017-01-29
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-24
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-02-25
• Study Start: 2021-04-01
• Primary Completion: 2021-08-24
• Study Completion: 2021-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients with active lesions

Exclusion Criteria

• Patients on a treatment
• Asymptomatic patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin A	Vitamin A	retinyl palmitate USP
Azithromycin with Vitamin A	Vitamin A	USP grade ingredients
Azithromycin with Vitamin A	Azithromycin	USP grade ingredients
Azithromycin	Azithromycin	azithromycin monohydrate

Primary Outcome Measures

Name	Time	Method
Measurement (dimensions) of acne lesions	Every 4 weeks up to16 weeks	follow-up focussed on observation of changes

Trial Locations

Locations (1)

Manchanda Mc; 🇨🇦 Surrey, British Columbia, Canada