Vitamin A and Azithromycin for Acne Vulgaris

February 24, 2021 updated by: DR. VINOD C TAWAR, Manchanda Medical Clinic

Treatment of Acne for Cases Resistant to Currently Available Measures Via Vitamin A With or Without Azithromycin in Topical Formulations

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3W2T2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with active lesions

Exclusion Criteria:

  • Patients on a treatment
  • Asymptomatic patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin A
retinyl palmitate USP
Drug: Vitamin A
Vitamin A 2-3 % concentration
Other Names:
  • retinyl palmitate
Experimental: Azithromycin with Vitamin A
USP grade ingredients
Drug: Vitamin A
Vitamin A 2-3 % concentration
Other Names:
  • retinyl palmitate
Drug: Azithromycin
azithromycin monohydrate
Other Names:
  • azithromycin monohydrate
Active Comparator: Azithromycin
azithromycin monohydrate
Drug: Azithromycin
azithromycin monohydrate
Other Names:
  • azithromycin monohydrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement (dimensions) of acne lesions
Time Frame: Every 4 weeks up to16 weeks
follow-up focussed on observation of changes
Every 4 weeks up to16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manchanda Medical Clinic

Investigators

  • Study Director: Vinod C Tawar, M.D.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2021

Primary Completion (Anticipated)

August 24, 2021

Study Completion (Anticipated)

October 31, 2021

Study Registration Dates

First Submitted

January 29, 2017

First Submitted That Met QC Criteria

March 21, 2017

First Posted (Actual)

March 24, 2017

Study Record Updates

Last Update Posted (Actual)

February 25, 2021

Last Update Submitted That Met QC Criteria

February 24, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tawar -1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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