Vitamin A and Azithromycin for Acne Vulgaris
Treatment of Acne for Cases Resistant to Currently Available Measures Via Vitamin A With or Without Azithromycin in Topical Formulations
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Apr 2021
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2017
CompletedFirst Posted
Study publicly available on registry
March 24, 2017
CompletedStudy Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 24, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2021
CompletedFebruary 25, 2021
February 1, 2021
5 months
January 29, 2017
February 24, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Measurement (dimensions) of acne lesions
follow-up focussed on observation of changes
Every 4 weeks up to16 weeks
Study Arms (3)
Vitamin A
EXPERIMENTALretinyl palmitate USP
Azithromycin with Vitamin A
EXPERIMENTALUSP grade ingredients
Azithromycin
ACTIVE COMPARATORazithromycin monohydrate
Interventions
Vitamin A 2-3 % concentration
azithromycin monohydrate
Eligibility Criteria
You may qualify if:
- Patients with active lesions
You may not qualify if:
- Patients on a treatment
- Asymptomatic patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Manchanda Mc
Surrey, British Columbia, V3W2T2, Canada
Related Publications (1)
Bartlett KB, Davis SA, Feldman SR. Tolerability of topical antimicrobials in treatment of acne vulgaris. J Drugs Dermatol. 2014 Jun;13(6):658-62.
PMID: 24918554RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Vinod C Tawar
M.D.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
January 29, 2017
First Posted
March 24, 2017
Study Start
April 1, 2021
Primary Completion
August 24, 2021
Study Completion
October 31, 2021
Last Updated
February 25, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share