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Vitamin A and Azithromycin for Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status

Unknown status

Phase

Early Phase 1

Locations

Canada

Study Type

Interventional

Intervention

Vitamin A

Azithromycin

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

12 Years - 45 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients with active lesions

Exclusion Criteria:

Patients on a treatment
Asymptomatic patients

Sites / Locations

Manchanda Mc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Vitamin A

Azithromycin with Vitamin A

Azithromycin

Arm Description

retinyl palmitate USP

USP grade ingredients

azithromycin monohydrate

Outcomes

Primary Outcome Measures

Measurement (dimensions) of acne lesions

follow-up focussed on observation of changes

Secondary Outcome Measures

Full Information

NCT ID

NCT03090048

First Posted

January 29, 2017

Last Updated

February 24, 2021

Sponsor

Manchanda Medical Clinic

1. Study Identification

Unique Protocol Identification Number

NCT03090048

Brief Title

Vitamin A and Azithromycin for Acne Vulgaris

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2021 (Anticipated)

Primary Completion Date

August 24, 2021 (Anticipated)

Study Completion Date

October 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Manchanda Medical Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Vulgaris

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Vitamin A

Arm Type

Experimental

Arm Description

retinyl palmitate USP

Arm Title

Azithromycin with Vitamin A

Arm Type

Experimental

Arm Description

USP grade ingredients

Arm Title

Azithromycin

Arm Type

Active Comparator

Arm Description

azithromycin monohydrate

Intervention Type

Drug

Intervention Name(s)

Vitamin A

Other Intervention Name(s)

retinyl palmitate

Intervention Description

Vitamin A 2-3 % concentration

Intervention Type

Drug

Intervention Name(s)

Azithromycin

Other Intervention Name(s)

azithromycin monohydrate

Intervention Description

azithromycin monohydrate

Primary Outcome Measure Information:

Title

Measurement (dimensions) of acne lesions

Description

follow-up focussed on observation of changes

Time Frame

Every 4 weeks up to16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with active lesions Exclusion Criteria: Patients on a treatment Asymptomatic patients

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Vinod C Tawar, M.Sc., M.D.

Phone

604 754 2235

Tawar.vinod@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vinod C Tawar

Organizational Affiliation

M.D.

Official's Role

Study Director

Facility Information:

Facility Name

Manchanda Mc

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3W2T2

Country

Canada

Facility Contact:

First Name & Middle Initial & Last Name & Degree

VINOD TAWAR, MD

Phone

604 754 2235

TAWAR.VINOD@YAHOO.COM

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

24918554

Citation

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

Results Reference

result

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Vitamin A and Azithromycin for Acne Vulgaris

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