Comparison of Microneedling Along With Topical Vitamin D3 Versus Microneedling in Alopecia Areata

NCT ID: NCT07243977

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-29
• Study Completion Date: 2025-12-29

Brief Summary

Alopecia areata is a common condition that causes sudden, patchy hair loss on the scalp and other body sites. It is believed to occur when the body's immune system mistakenly attacks the hair follicles, leading to hair loss that can range from small patches to more widespread involvement. While many treatments have been tried, including steroids and newer medicines, none offer a guaranteed permanent cure.

Microneedling is a technique in which very fine needles are used to create small punctures in the skin. This stimulates natural healing, improves blood supply to hair roots, and activates stem cells that support new hair growth. It also allows medicines applied to the skin to penetrate more effectively. Previous studies have shown that combining microneedling with certain topical medicines improves results compared to microneedling alone.

Vitamin D is known to play an important role in the regulation of the immune system and in the health of hair follicles. Applying vitamin D directly to the scalp after microneedling may enhance its effects, as the microchannels created by the needles allow the medicine to reach the deeper layers of the skin.

This study will compare two treatment approaches for patients with localized alopecia areata (affecting less than half of the scalp). One group will receive microneedling alone, while the other group will receive microneedling combined with topical vitamin D3. The treatments will be given every two weeks for a total of six sessions. Patients will then be followed for three months to see whether they achieve complete regrowth of hair in the affected areas, as measured by a standard scoring system for alopecia areata (SALT score).

The study will enroll 80 adults aged 18-60 years who have alopecia areata and have not received any recent treatment. By comparing these two approaches, the study aims to find out whether adding topical vitamin D3 to microneedling improves treatment outcomes. If effective, this combination could provide patients with a safe, affordable, and non-invasive option for treating alopecia areata.

Conditions

Alopecia Areata

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group Microneedling + Vitamin D3

Received microneedling with a dermapen (needle length 1.5-2 mm, highest speed level 4-5) performed until pinpoint bleeding appeared, combined with topical vitamin D3 application (Sunny D3® 200,000 IU/1 ml, aqueous preparation). Half the dose of vitamin D3 was applied before microneedling and the remaining after the procedure. Maximum dose used per session was 2.5 mg (0.5 ml). Sessions were repeated every 2 weeks for up to 6 sessions.

Group Type: EXPERIMENTAL

Microneedling + Vitamin D3

Intervention Type: PROCEDURE

Dermapen treatment with adjustable needle length (1.5-2 mm), performed under local anaesthesia until pinpoint bleeding appeared. Aqueous vitamin D3 solution (Sunny D3® 200,000 IU/1 ml, 5 mg/ml) applied topically before and after microneedling.

Group Microneedling Alone

Received microneedling with a dermapen (needle length 1.5-2 mm, highest speed level 4-5) performed until pinpoint bleeding appeared, without vitamin D3 application. Sessions were repeated every 2 weeks for up to 6 sessions.

Group Type: ACTIVE_COMPARATOR

Microneedling

Intervention Type: PROCEDURE

Dermapen treatment with adjustable needle length (1.5-2 mm), performed under local anaesthesia until pinpoint bleeding appeared.

Interventions

Microneedling + Vitamin D3

Dermapen treatment with adjustable needle length (1.5-2 mm), performed under local anaesthesia until pinpoint bleeding appeared. Aqueous vitamin D3 solution (Sunny D3® 200,000 IU/1 ml, 5 mg/ml) applied topically before and after microneedling.

Intervention Type: PROCEDURE

Microneedling

Dermapen treatment with adjustable needle length (1.5-2 mm), performed under local anaesthesia until pinpoint bleeding appeared.

Intervention Type: PROCEDURE

Other Intervention Names

Cholecalciferol topical solution; Microneedling

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed with Alopecia Areata and have not received any treatment for last 4 weeks.
• Age range of 18-60 years
• Both male and female patients

Exclusion Criteria

• Active infection or atrophy of scalp due to previous treatment
• Patients with alopecia universalis or totalis.
• Pregnant or lactating mothers.
• Systemic co-morbidities like diabetes, hypertension, chronic liver or kidney disease and immunosuppression
• Unwilling or uncooperative patients

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Services Institute of Medical Sciences, Pakistan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Rameen Masood

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rameen Masood

Role: PRINCIPAL_INVESTIGATOR

Services Institute of Medical Sciences, Lahore

Locations

Services Institute of Medical Sciences, Lahore

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

ServicesIMSP1

Identifier Type: -

Identifier Source: org_study_id