Vitamin D Supplementation in Acne | NCT06141330

Studies
Vitamin D Supplementation in Acne

NCT06141330

Sponsor

HITEC-Institute of Medical Sciences

Status

Completed

Last Update Posted

May 19, 2026Actual

Enrollment

58Actual

Phase

Not Applicable

Conditions

Acne Vulgaris

Interventions

D Max Drops
Azithromycin 250 milligram Oral Capsule
Adapalene

Countries

Pakistan

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

May 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 24, 2024Actual

Primary Completion Date

Feb 24, 2025Actual

Completion Date

Aug 24, 2025Actual

First Submitted Date

Oct 23, 2023

First Submission Date that Met QC Criteria

Nov 19, 2023

First Posted Date

Nov 21, 2023Actual

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

May 15, 2026

Last Update Posted Date

May 19, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Aqsa Naheed, Professor, MBBS, FCPS, HITEC-Institute of Medical SciencesPrincipal Investigator

Lead Sponsor

HITEC-Institute of Medical SciencesOTHER

Collaborators

Not provided

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this clinical trial is to compare in acne vulgaris patients. The main question it aims to answer is:

• To assess the therapeutic benefit of vitamin D supplement in acne vulgaris treatment, following a 2-month treatment regimen that includes vitamin D supplementation compared to conventional (systemic azithromycin and topical retinoid) treatment alone.

Participants will receive vitamin D supplements in addition to capsule Azithromycin and topical retinoid.

Researchers will compare groups to determine efficacy of Vitamin D supplements in the treatment of Acne vulgaris.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

58Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitamin D	Experimental		Dietary Supplement: D Max Drops Drug: Azithromycin 250 milligram Oral Capsule Drug: Adapalene
Placebo	Active Comparator		Drug: Azithromycin 250 milligram Oral Capsule Drug: Adapalene

Interventions

Name	Type	Description	Arm Group Labels	Other Names
D Max Drops	Dietary Supplement	Vitamin D	Vitamin D
Azithromycin 250 milligram Oral Capsule

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacious	Improvement in Global Acne Grading System Score from baseline to after 2 months of treatment	2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Individuals aged between 13 and 40 years with diagnoses of Acne vulgaris are included.

Exclusion Criteria:

Individuals currently undergoing treatment for polycystic ovary syndrome (PCOs)
Those with obesity
Individuals employing vitamin supplementation
Those under the influence of topical or systemic steroids and acne treatment in the last 2 months.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hitec-Ims		Islamabad	Punjab Province	47080	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

not sharing

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000152	Acne Vulgaris

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068816	Adapalene

Ancestor Terms

ID	Term
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided