NCT06141330

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

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

October 23, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

February 24, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2025

Completed
Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

October 23, 2023

Last Update Submit

May 15, 2026

Conditions

Acne Vulgaris

Keywords

AcneVulgarisVitamin D

Outcome Measures

Primary Outcomes (1)

  • Efficacious

    Improvement in Global Acne Grading System Score from baseline to after 2 months of treatment

    2 months

Study Arms (2)

Vitamin D

EXPERIMENTAL
Dietary Supplement: D Max DropsDrug: Azithromycin 250 milligram Oral CapsuleDrug: Adapalene

Placebo

ACTIVE COMPARATOR
Drug: Azithromycin 250 milligram Oral CapsuleDrug: Adapalene

Interventions

D Max DropsDIETARY_SUPPLEMENT

Vitamin D

Vitamin D
AdapaleneDRUG

Retinoid

PlaceboVitamin D
Azithromycin 250 milligram Oral CapsuleDRUG

Anti Biotic

PlaceboVitamin D

Eligibility Criteria

Age13 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hitec-Ims

Islamabad, Punjab Province, 47080, Pakistan

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Adapalene

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MBBS, FCPS

Study Record Dates

First Submitted

October 23, 2023

First Posted

November 21, 2023

Study Start

February 24, 2024

Primary Completion

February 24, 2025

Study Completion

August 24, 2025

Last Updated

May 19, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

not sharing

Locations

PA(1)