Vitamin A and Azithromycin for Acne Vulgaris

• ClinicalTrials.gov Identifier: NCT03090048
• Recruitment Status: Unknown
• First Posted: March 24, 2017
• Last Update Posted: February 25, 2021
• Sponsor: Manchanda Medical Clinic
• Information provided by (Responsible Party): DR. VINOD C TAWAR, Manchanda Medical Clinic

Tracking Information

• First Submitted Date: January 29, 2017
• First Posted Date: March 24, 2017
• Last Update Posted Date: February 25, 2021
• Estimated Study Start Date: April 1, 2021
• Estimated Primary Completion Date: August 24, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment
• Condition: Acne Vulgaris

Intervention

• Drug: Vitamin A
  Vitamin A 2-3 % concentration
  Other Name: retinyl palmitate
• Drug: Azithromycin
  azithromycin monohydrate
  Other Name: azithromycin monohydrate

Study Arms

• Experimental: Vitamin A
  retinyl palmitate USP
  Intervention: Drug: Vitamin A
• Experimental: Azithromycin with Vitamin A
  USP grade ingredients
  Interventions:

  • 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: March 21, 2017): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 31, 2021
• Estimated Primary Completion Date: August 24, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients with active lesions

Exclusion Criteria:

• Patients on a treatment
• Asymptomatic patients

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years to 45 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT03090048
• Other Study ID Numbers: 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

• Plan to Share IPD: Yes

• Current Responsible Party: DR. VINOD C TAWAR, Manchanda Medical Clinic
• Original Responsible Party: Same as current
• Current Study Sponsor: Manchanda Medical Clinic
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Vinod C Tawar; M.D.

• PRS Account: Manchanda Medical Clinic
• Verification Date: February 2021