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Trial record 2 of 132 for:    Recruiting, Not yet recruiting, Available Studies | "Vitamin A"

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

Tracking Information
First Submitted Date  ICMJE January 29, 2017
First Posted Date  ICMJE March 24, 2017
Last Update Posted Date May 20, 2020
Estimated Study Start Date  ICMJE September 1, 2020
Estimated Primary Completion Date December 24, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2017)
Measurement (dimensions) of acne lesions [ Time Frame: Every 4 weeks up to16 weeks ]
follow-up focussed on observation of changes
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Vitamin A and Azithromycin for Acne Vulgaris
Official Title  ICMJE Treatment of Acne for Cases Resistant to Currently Available Measures Via Vitamin A With or Without Azithromycin in Topical Formulations
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: Vitamin A
    Vitamin A 2-3 % concentration
    Other Name: retinyl palmitate
  • Drug: Azithromycin
    azithromycin monohydrate
    Other Name: azithromycin monohydrate
Study Arms  ICMJE
  • Experimental: Vitamin A
    retinyl palmitate USP
    Intervention: Drug: Vitamin A
  • Experimental: Azithromycin with Vitamin A
    USP grade ingredients
    • Drug: Vitamin A
    • Drug: Azithromycin
  • Active Comparator: Azithromycin
    azithromycin monohydrate
    Intervention: Drug: Azithromycin
Publications * Bartlett KB, Davis SA, Feldman SR. Tolerability of topical antimicrobials in treatment of acne vulgaris. J Drugs Dermatol. 2014 Jun;13(6):658-62. Review.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 21, 2017)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2021
Estimated Primary Completion Date December 24, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with active lesions

Exclusion Criteria:

  • Patients on a treatment
  • Asymptomatic patients
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Vinod C Tawar, M.Sc., M.D. 604 754 2235
Listed Location Countries  ICMJE Canada
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03090048
Other Study ID Numbers  ICMJE Tawar -1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party DR. VINOD C TAWAR, Manchanda Medical Clinic
Study Sponsor  ICMJE Manchanda Medical Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Vinod C Tawar M.D.
PRS Account Manchanda Medical Clinic
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP