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NCT Number: NCT07243977

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Services Institute of Medical Sciences, Lahore

Lahore, Punjab Province, 54000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microneedling + Vitamin D3

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.

Other names: Cholecalciferol topical solution, Microneedling

Microneedling

Procedure

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

Primary outcomes

  1. Proportion of patients achieving complete hair regrowth (S0 on SALT score)

    Time frame: 3 months after initiation of treatment (following up to 6 treatment sessions given at 2-week intervals).

    The Severity of Alopecia Tool (SALT) score will be used to measure the extent of scalp hair loss. The scale ranges from S0 (no hair loss, complete regrowth) to S5 (100% hair loss). Treatment will be considered effective if participants achieve S0 (complete hair regrowth with no hair loss) at the end of the study period compared with baseline assessment. Clinical photographs and dermoscopic findings will also be used to validate outcomes.

Secondary outcomes

  1. Dermoscopic improvement in alopecia areata lesions.

    Time frame: From baseline to 3 months after treatment initiation

    Assessment of dermoscopic features with documentation of new vellus hair growth as an indicator of follicular regeneration.

Sponsors and collaborators

Lead sponsor

Services Institute of Medical Sciences, Pakistan

Other Gov

Registry information

Official study title

Comparison of Efficacy of Microneedling Along With Topical Vitamin D3 Versus Microneedling Alone in the Treatment of Alopecia Areata

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 24, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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