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Status unknownNCT03090048Updated Feb 25, 2021

Vitamin A and Azithromycin for Acne Vulgaris

An Early Phase 1 interventional study of Vitamin A and Azithromycin in Acne Vulgaris, sponsored by Manchanda Medical Clinic. Status unknown at 1 site in Canada. Open to participants aged 12 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-25.

Sponsored by Manchanda Medical Clinic · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
12 Years to 45 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acne Vulgaris

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03

In context

Acne Vulgaris

730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.

This study's planned enrollment of 30 is below the median of 69 across 628 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Manchanda Medical Clinic is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients with active lesions

Exclusion criteria

Exclusion Criteria:

  • Patients on a treatment
  • Asymptomatic patients
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Vitamin A

    retinyl palmitate USP

    Drug: Vitamin A

  • Experimental
    Azithromycin with Vitamin A

    USP grade ingredients

    Drug: Vitamin A · Drug: Azithromycin

  • Active comparator
    Azithromycin

    azithromycin monohydrate

    Drug: Azithromycin

Interventions

  • DrugVitamin A

    Vitamin A 2-3 % concentration

    Also known as: retinyl palmitate

  • DrugAzithromycin

    azithromycin monohydrate

    Also known as: azithromycin monohydrate

06

What researchers measure

Primary outcomes

  1. Measurement (dimensions) of acne lesions

    follow-up focussed on observation of changes

    Time frame: Every 4 weeks up to16 weeks

07

Study locations

1 site
  • Manchanda Mc
    Surrey, British Columbia V3W2T2, Canada
08

References and documents

Publications

  • Bartlett KB, Davis SA, Feldman SR. Tolerability of topical antimicrobials in treatment of acne vulgaris. J Drugs Dermatol. 2014 Jun;13(6):658-62. PubMed 24918554 ↗

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03090048
Lead sponsor
Manchanda Medical Clinic
Responsible party
DR. VINOD C TAWAR (Principal investigator, Manchanda Medical Clinic) — Principal investigator
First posted
Mar 24, 2017
Start date
Apr 1, 2021 (estimated)
Primary completion
Aug 24, 2021 (estimated)
Completion
Oct 31, 2021 (estimated)
Last update
Feb 25, 2021

Study contacts

Vinod C Tawar, M.Sc., M.D.
Contact
Tawar.vinod@yahoo.com
604 754 2235
Vinod C Tawar
study director · M.D.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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