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Vitamin A and Azithromycin for Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03090048
Recruitment Status : Not yet recruiting
First Posted : March 24, 2017
Last Update Posted : May 20, 2020
Information provided by (Responsible Party):
DR. VINOD C TAWAR, 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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Vitamin A Drug: Azithromycin Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Acne for Cases Resistant to Currently Available Measures Via Vitamin A With or Without Azithromycin in Topical Formulations
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : December 24, 2020
Estimated Study Completion Date : March 31, 2021

Arm Intervention/treatment
Experimental: Vitamin A
retinyl palmitate USP
Drug: Vitamin A
Vitamin A 2-3 % concentration
Other Name: retinyl palmitate

Experimental: Azithromycin with Vitamin A
USP grade ingredients
Drug: Vitamin A
Vitamin A 2-3 % concentration
Other Name: retinyl palmitate

Drug: Azithromycin
azithromycin monohydrate
Other Name: azithromycin monohydrate

Active Comparator: Azithromycin
azithromycin monohydrate
Drug: Azithromycin
azithromycin monohydrate
Other Name: azithromycin monohydrate

Primary Outcome Measures :
  1. Measurement (dimensions) of acne lesions [ Time Frame: Every 4 weeks up to16 weeks ]
    follow-up focussed on observation of changes

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients with active lesions

Exclusion Criteria:

  • Patients on a treatment
  • Asymptomatic patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03090048

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Contact: Vinod C Tawar, M.Sc., M.D. 604 754 2235

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Canada, British Columbia
Manchanda Mc
Surrey, British Columbia, Canada, V3W2T2
Contact: VINOD TAWAR, MD    604 754 2235    TAWAR.VINOD@YAHOO.COM   
Sponsors and Collaborators
Manchanda Medical Clinic
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Study Director: Vinod C Tawar M.D.
Publications of Results:
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Responsible Party: DR. VINOD C TAWAR, Principal investigator, Manchanda Medical Clinic Identifier: NCT03090048    
Other Study ID Numbers: Tawar -1
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Vitamin A
Retinol palmitate
Growth Substances
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents