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

Services Institute of Medical Sciences, Pakistan

Status: Active, not recruiting

Conditions: Alopecia Areata

Treatments: Procedure: Microneedling; Procedure: Microneedling + Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT07243977

ServicesIMSP1

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Group Microneedling + Vitamin D3

Experimental group

Description:

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.

Treatment:

Procedure: Microneedling + Vitamin D3

Group Microneedling Alone

Active Comparator group

Description:

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.

Treatment:

Procedure: Microneedling