Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Microneedling + Vitamin D3 | Experimental | 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 Microneedling Alone | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving complete hair regrowth (S0 on SALT score) | 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. | 3 months after initiation of treatment (following up to 6 treatment sessions given at 2-week intervals). |
| Measure | Description | Time Frame |
|---|---|---|
| Dermoscopic improvement in alopecia areata lesions. | Assessment of dermoscopic features with documentation of new vellus hair growth as an indicator of follicular regeneration. | From baseline to 3 months after treatment initiation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rameen Masood | Services Institute of Medical Sciences, Pakistan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Services Institute of Medical Sciences, Lahore | Lahore | Punjab Province | 54000 | Pakistan |
Not provided
| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000097244 | Percutaneous Collagen Induction |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D011677 | Punctures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Microneedling | Procedure | Dermapen treatment with adjustable needle length (1.5-2 mm), performed under local anaesthesia until pinpoint bleeding appeared. |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D012046 |
| Rehabilitation |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |