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Vitamin A and Azithromycin for Acne Vulgaris

Sponsor
Manchanda Medical Clinic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT03090048
Collaborator
(none)
30
Enrollment
1
Location
3
Arms
7
Anticipated Duration (Months)
4.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
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

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Aug 24, 2021
Anticipated Study Completion Date :
Oct 31, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Measurement (dimensions) of acne lesions [Every 4 weeks up to16 weeks]

      follow-up focussed on observation of changes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Patients with active lesions
    Exclusion Criteria:

    • Patients on a treatment

    • Asymptomatic patients

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Manchanda Mc Surrey British Columbia Canada V3W2T2

    Sponsors and Collaborators

    • Manchanda Medical Clinic

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    DR. VINOD C TAWAR, Principal investigator, Manchanda Medical Clinic
    ClinicalTrials.gov Identifier:
    NCT03090048
    Other Study ID Numbers:
    • Tawar -1
    First Posted:
    Mar 24, 2017
    Last Update Posted:
    Feb 25, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Acne Vulgaris
    Vitamin A
    Azithromycin
    Retinol palmitate

    Study Results

    No Results Posted as of Feb 25, 2021