Vitamin A and Azithromycin for Acne Vulgaris

NCT ID: NCT03090048

Last Updated: 2021-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2021-10-31

Brief Summary

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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

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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.

Conditions

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Acne Vulgaris

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Vitamin A

retinyl palmitate USP

Group Type EXPERIMENTAL

Vitamin A

Intervention Type DRUG

Vitamin A 2-3 % concentration

Azithromycin with Vitamin A

USP grade ingredients

Group Type EXPERIMENTAL

Vitamin A

Intervention Type DRUG

Vitamin A 2-3 % concentration

Azithromycin

Intervention Type DRUG

azithromycin monohydrate

Azithromycin

azithromycin monohydrate

Group Type ACTIVE_COMPARATOR

Azithromycin

Intervention Type DRUG

azithromycin monohydrate

Interventions

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Vitamin A

Vitamin A 2-3 % concentration

Intervention Type DRUG

Azithromycin

azithromycin monohydrate

Intervention Type DRUG

Other Intervention Names

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retinyl palmitate azithromycin monohydrate

Eligibility Criteria

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Inclusion Criteria

* Patients with active lesions

Exclusion Criteria

* Patients on a treatment
* Asymptomatic patients
Minimum Eligible Age

12 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Manchanda Medical Clinic

OTHER

Sponsor Role lead

Responsible Party

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DR. VINOD C TAWAR

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vinod C Tawar

Role: STUDY_DIRECTOR

M.D.

Locations

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Manchanda Mc

Surrey, British Columbia, Canada

Site Status

Countries

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Canada

Central Contacts

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Vinod C Tawar, M.Sc., M.D.

Role: CONTACT

604 754 2235

Facility Contacts

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VINOD TAWAR, MD

Role: primary

604 754 2235

References

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Bartlett KB, Davis SA, Feldman SR. Tolerability of topical antimicrobials in treatment of acne vulgaris. J Drugs Dermatol. 2014 Jun;13(6):658-62.

Reference Type RESULT
PMID: 24918554 (View on PubMed)

Other Identifiers

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Tawar -1

Identifier Type: -

Identifier Source: org_study_id

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