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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03090048
Recruitment Status : Unknown
Verified February 2021 by DR. VINOD C TAWAR, Manchanda Medical Clinic.
Recruitment status was:  Not yet recruiting
First Posted : March 24, 2017
Last Update Posted : February 25, 2021
Sponsor:
Information provided by (Responsible Party):
DR. VINOD C TAWAR, Manchanda Medical Clinic

Study Description
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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.
Study Design
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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 : April 1, 2021
Estimated Primary Completion Date : August 24, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Vitamin A

Arms and Interventions
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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


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


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

Inclusion Criteria:

  • Patients with active lesions

Exclusion Criteria:

  • Patients on a treatment
  • Asymptomatic patients
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03090048


Contacts
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Contact: Vinod C Tawar, M.Sc., M.D. 604 754 2235 Tawar.vinod@yahoo.com

Locations
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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
Investigators
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Study Director: Vinod C Tawar M.D.
More Information
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Publications of Results:

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Responsible Party: DR. VINOD C TAWAR, Principal investigator, Manchanda Medical Clinic
ClinicalTrials.gov Identifier: NCT03090048    
Other Study ID Numbers: Tawar -1
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021
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
Azithromycin
Retinol palmitate
Vitamins
Micronutrients
 Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents