Alopecia AreataNCT07243977
Comparison of Microneedling Along With Topical Vitamin D3 Versus Microneedling in Alopecia Areata
A study testing Microneedling + Vitamin D3 and Microneedling in people with Alopecia Areata, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Microneedling + Vitamin D3 and Microneedling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 29 Mar 2025to 29 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Pakistan1 site
Services Institute of Medical Sciences, Lahore
Lahore, Punjab Province, 54000
About this study
Official title: Comparison of Efficacy of Microneedling Along With Topical Vitamin D3 Versus Microneedling Alone in the Treatment of 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.
Read more
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
- Being tested
- Microneedling + Vitamin D3, Microneedling
- Keywords
- Alopecia Areata, Autoimmune Hair Loss, Microneedling, Hair Follicle Regeneration
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microneedling + Vitamin D3Procedure or surgery
Also called Cholecalciferol topical solution, Microneedling
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.
MicroneedlingProcedure or surgery
Dermapen treatment with adjustable needle length (1.5-2 mm), performed under local anaesthesia until pinpoint bleeding appeared.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Microneedling + Vitamin D3 |
| 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. Receives: Procedure: Microneedling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after initiation of treatment (following up to 6 treatment sessions given at 2-week intervals).
Secondary outcomes (1)
Dermoscopic improvement in alopecia areata lesions.
Assessment of dermoscopic features with documentation of new vellus hair growth as an indicator of follicular regeneration.
Measured: From baseline to 3 months after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start29 Mar 2025
- Primary completion29 Sep 2025
- Study completion29 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Institute of Medical Sciences, Pakistan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rameen Masood, Services Institute of Medical Sciences, Pakistan
- Investigators
- Rameen Masood, Principal investigator, Services Institute of Medical Sciences, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243977
- Sponsor's protocol ID
- ServicesIMSP1
- Status last verified
- Sep 2025
- First submitted
- 21 Sep 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Microneedling Along With Topical Vitamin D3 Versus Microneedling Alone in the Treatment of Alopecia Areata
- ClinicalTrials.gov ID
- NCT07243977
- Acronym / sponsor ID
- ServicesIMSP1
- Conditions
- Alopecia Areata
- Keywords
- Alopecia Areata, Autoimmune Hair Loss, Microneedling, Hair Follicle Regeneration
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Services Institute of Medical Sciences, PakistanOther government
- Study start
- 29 Mar 2025 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 29 Dec 2025 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Microneedling + Vitamin D3 | Experimental | Procedure: Microneedling + Vitamin D3Received 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 | Procedure: MicroneedlingReceived 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microneedling + Vitamin D3Also: Cholecalciferol topical solution, MicroneedlingDermapen 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. | Procedure or surgery | Group Microneedling + Vitamin D3 |
| MicroneedlingDermapen treatment with adjustable needle length (1.5-2 mm), performed under local anaesthesia until pinpoint bleeding appeared. | Procedure or surgery | Group Microneedling Alone |
Primary outcome
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.
1 secondary outcome
Dermoscopic improvement in alopecia areata lesions.
Time frame: From baseline to 3 months after treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rameen Masood principal investigator
Services Institute of Medical Sciences, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microneedling + Vitamin D3 and Microneedling in people with Alopecia Areata, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.