Alopecia Areata
Conditions
Keywords
Alopecia Areata, Autoimmune Hair Loss, Microneedling, Hair Follicle Regeneration
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.
Interventions
PROCEDUREMicroneedling + 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.
PROCEDUREMicroneedling
Dermapen treatment with adjustable needle length (1.5-2 mm), performed under local anaesthesia until pinpoint bleeding appeared.
Sponsors
Services Institute of Medical Sciences, Pakistan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients achieving complete hair regrowth (S0 on SALT score) | 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
| Measure | Time frame | Description |
|---|---|---|
| Dermoscopic improvement in alopecia areata lesions. | 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. |
Countries
Pakistan
Outcome results
None listed