Vitamin A and Azithromycin for Acne Vulgaris | NCT03090048

Studies
Vitamin A and Azithromycin for Acne Vulgaris

NCT03090048

Sponsor

Manchanda Medical Clinic

Status

Unknown status

Last Update Posted

Feb 25, 2021Actual

Enrollment

30Estimated

Phase

Early Phase 1

Conditions

Acne Vulgaris

Interventions

Vitamin A
Azithromycin

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2021Estimated

Primary Completion Date

Aug 24, 2021Estimated

Completion Date

Oct 31, 2021Estimated

First Submitted Date

Jan 29, 2017

First Submission Date that Met QC Criteria

Mar 21, 2017

First Posted Date

Mar 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2021

Last Update Posted Date

Feb 25, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitamin A	Experimental	retinyl palmitate USP	Drug: Vitamin A
Azithromycin with Vitamin A	Experimental	USP grade ingredients	Drug: Vitamin A Drug: Azithromycin
Azithromycin	Active Comparator	azithromycin monohydrate	Drug: Azithromycin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin A	Drug	Vitamin A 2-3 % concentration	Azithromycin with Vitamin A Vitamin A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement (dimensions) of acne lesions	follow-up focussed on observation of changes	Every 4 weeks up to16 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with active lesions

Exclusion Criteria:

Patients on a treatment
Asymptomatic patients

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vinod C Tawar, M.Sc., M.D.	Contact	604 754 2235		Tawar.vinod@yahoo.com

Overall Officials

Name	Affiliation	Role
Vinod C Tawar	M.D.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Manchanda Mc		Surrey	British Columbia	V3W2T2	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24918554	Result	Bartlett KB, Davis SA, Feldman SR. Tolerability of topical antimicrobials in treatment of acne vulgaris. J Drugs Dermatol. 2014 Jun;13(6):658-62.

ID	Term
D017486	Acneiform Eruptions
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012625	Sebaceous Gland Diseases

ID	Term
D014801	Vitamin A
C014794	retinol palmitate
D017963	Azithromycin

ID	Term
D012176	Retinoids
D002338	Carotenoids
D011090	Polyenes
D000475	Alkenes
D006839