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Alopecia AreataNCT06327581

Combined Microneedling With Either 1% Lactic Acid Solution or Vitamin D3 or Triamcinolone Acetonide in The Treatment of Alopecia Areata

A study testing Lactic Acid, vit D and Triamcinolone Acetonide in people with Alopecia Areata, run by Zagazig University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Alopecia areata (AA) is an immunologically mediated disease characterized by non-scarring hair loss (Madni and Shapiro, 2000). AA is presented by rapid and complete hair loss in one or more round or oval patches, usually on the scalp, beard area, eyebrows, eyelashes, and less commonly, on other hairy areas of the body… Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Alopecia Areata
What is being tested?
Lactic Acid, vit D and Triamcinolone Acetonide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteEgypt
Study dates
15 Dec 2023to 30 Dec 2026
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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • · Age ≥ 16 years old with localized patchy AA (up to 6 cm in diameter).
  • Patients of both sexes
  • Willing to participate in the study and to sign an informed consent.

Who cannot join

  • · Patients who received systemic or topical treatment for AA in the last 3 months prior to the start of the study
  • Patients with Alopecia totalis, universalis, ophiasis, or sisaipho
  • Pregnant or lactating females
  • Patients who had bleeding or coagulation disorders
  • Immunocompromised patients
  • Patients with known history of hypersensitivity to vit D
  • Patients taking vitamin D supplements in the last 6 months.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

rana ehab hamed ehab, md contact

0201000896453

ranaehab015@gmail.com

Egypt1 site, 1 recruiting
  • Rana Ehab

    Zagazig, 44519

    rana ehab, md, 01000896453, ranaehab015@gmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: Comparative Study of Combined Microneedling With Either 1% Lactic Acid Solution or Vitamin D3 or Triamcinolone Acetonide in The Treatment of Alopecia Areata

Alopecia areata (AA) is an immunologically mediated disease characterized by non-scarring hair loss (Madni and Shapiro, 2000). AA is presented by rapid and complete hair loss in one or more round or oval patches, usually on the scalp, beard area, eyebrows, eyelashes, and less commonly, on other hairy areas of the body (Berker et al., 2010 and James et al., 2011) Alopecia areata is a T-cell-mediated autoimmune disease. There is a complicated interplay between loss of immune privilege in the hair follicle, autoimmune-mediated hair follicle damage, and activation of inflammatory pathways that have been argued to explain the development of this disorder, but the exact pathophysiology of AA remains unknown. Hair follicles are infiltrated by autoreactive CD8 and CD4 T lymphocytes, which attack hair follicle-derived autoantigens while sparing the stem compartment (Rajabi et al., 2018).

Alopecia areata can be treated with topical and/or intralesional corticosteroids, which are the treatment of choice. Anthralin, minoxidil, coal tar, and topical immunotherapy are examples of other topical treatments. Systemic immunosuppressants such as cyclosporine, systemic steroids, Janus kinase inhibitors, and methotrexate may be considered in severe resistant cases (lee and lee, 2017).

Read more

Intralesional triamcinolone acetonide is preferred in cases of AA , as it is well known as anti-inflammatory and interferes with local immunity of the skin, which helps in the recovery of the disease, but if used in wrong technique or given in a high dose, it might cause all the side effects of corticosteroid, especially skin atrophy (Berker et al., 2010).

Lactic acid is a member of alpha-hydroxy acids. It has been used in the treatment of many skin diseases, like AA and vitiligo. Lactic acid stimulates spontaneous secretion of vascular endothelial growth factor (VEGF) by human reconstructed epidermis. VEGF is an angiogenic cytokine involved in angiogenesis and wound healing and stimulates the growth of hair follicles resulting in recovery of AA. Other studies suggest that lactic acid may act through its irritant effect (Al-Tammimy, 2005).

Vitamin D interacts with the innate and adaptive immune systems in a variety of ways, the majority of which contribute to its downregulation (Nancy and Yehuda, 2009). It has a powerful effect on T and B lymphocytes, influencing their activation responses (Arnson et al., 2007).

All cells of the immune system express 1,25-dihydroxyvitamin D3 receptors (VDRs) and are therefore vulnerable to calcitriol-mediated modulation. Vitamin D3 has the ability to influence the migration and maturation of different dendritic cell subtypes and their production of chemokines and cytokines, giving them an immunoregulatory and tolerogenic role (Illescas-Montes et al., 2019) It has been shown that VDRs are highly expressed in the keratinocytes of human hair follicles and the absence of their expression is associated with reduced hair follicle growth and epidermal differentiation. Reduced VDR expression in the hair follicles of affected areas has also been observed in studies of AA patients' scalp (Çerman et al., 2015).

Microneedling (MN) is a technique that comprises puncturing the skin repeatedly with sterile microneedles (Iriarte et al., 2017). It promotes hair regeneration by triggering stem cells in the hair bulge, which results in the generation of growth factors. It also improves blood circulation to the hair follicles and influences the local immune cells (Chandrashekar et al., 2014). Moreover, combining MN with applied topical drugs facilitates their absorption through the microchannels created within the epidermis (Fertig et al., 2018).

Read the detailed description

Patients in all groups will be subjected to microneedling (MN) using a dermapen "Dr.Pen") with adjustable needle length ranging from 1.5 to 2 mm, using the highest speed level (4-5). First, topical anesthetic cream will be applied. Then, they will be stroked by dermapen diagonally, vertically, and horizontally in a repeated manner until pinpoint bleeding appears which will be regarded as an endpoint.

  • First group (A): 22 AA patients will be treated with MN combined with lactic acid solution 1%. (Sharquis et al., 2015).
  • Second group (B): 22 AA patients will be treated with MN combined with topical application of vitamin D3 (an aqueous preparation of cholecalciferol (Devarol® ampoule 200 000 IU/2 ml, Memphis, Egypt) (2.5 mg/ ml), The maximum total amount of vitamin D3 injected into a patient in every session will be 2.5 mg (1 ml) (Ali et al., 2023).
  • Third group (C): 22 AA patients will be treated with MN combined with triamcinolone acetonide injectable suspension (Epirelefan®, 40mg/ ml, Eipico, Egypt) (10 mg/ml) will be used in a dose of 0.1 ml/cm2 area (Arora et al., 2022).
  • Fourth group (D): 22 AA patients will be treated with MN combined with normal saline 0.9% In all groups, sessions were done every 2 weeks for a maximum of six sessions. V. Photographs will be taken by (Iphone 13 pro max Camera) before, during and after treatment.
Conditions
Alopecia Areata
Being tested
Lactic Acid, vit D, Triamcinolone Acetonide, Saline
Medical subject headings
Alopecia Areata

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lactic AcidDrug

    patients will be treated with MN combined with lactic acid solution 1%.

  • vit DDrug

    patients will be treated with MN combined with topical application of vitamin D3 (an aqueous preparation of cholecalciferol (2.5 mg/ ml), The maximum total amount of vitamin D3 injected into a patient in every session will be 2.5 mg (1 ml)

  • Triamcinolone AcetonideDrug

    patients will be treated with MN combined with triamcinolone acetonide injectable suspension (Epirelefan®, 40mg/ ml, Eipico, Egypt) (10 mg/ml) will be used in a dose of 0.1 ml/cm2 area

  • SalineDrug

    patients will be treated with MN combined with normal saline 0.9%

Study groups in NCT06327581
Study groupRoleWhat they receive
lactic acid groupExperimental· First group (A): 22 AA patients will be treated with MN combined with lactic acid solution 1%.
Receives: Drug: Lactic Acid
vitamin d3Experimental· Second group (B):22 AA patients will be treated with MN combined with topical application of vitamin D3 (an aqueous preparation of cholecalciferol (Devarol® ampoule 200 000 IU/2 ml, Memphis, Egypt) (2.5 mg/ ml), The maximum total amount of vitamin D3 injected into a patient in every session will be 2.5 mg (1 ml)
Receives: Drug: vit D
triamcinolone acetonide groupExperimental· Third group (C): 22 AA patients will be treated with MN combined with triamcinolone acetonide injectable suspension (Epirelefan®, 40mg/ ml, Eipico, Egypt) (10 mg/ml) will be used in a dose of 0.1 ml/cm2 area
Receives: Drug: Triamcinolone Acetonide
salineExperimental· Fourth group (D): 22 AA patients will be treated with MN combined with normal saline 0.9%
Receives: Drug: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. hair regrowth improvement assessed by SALT score and percaentage of hair growth

    Clinical scoring: The evaluation of therapeutic response will be carried out by three blinded investigators to determine the percentage of improvement as follows using SALT score and percentage of hair growth (A0 = no change or further hair loss, A1=1-24% regrowth, A2= 25-49%, A3=50-74%, A4= 75-99%, A5= 100% regrowth

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2024
  2. Study start15 Dec 2023
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

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
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06327581
Sponsor's protocol ID
101005
Status last verified
Jan 2026
First submitted
18 Mar 2024
Last updated
26 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Lactic Acid, vit D and Triamcinolone Acetonide in people with Alopecia Areata, run by Zagazig University at 1 site in Egypt.

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 7 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: looking for participants now, as of the sponsor's last update on 26 Jan 2026. 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 Egypt. 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?

Contact rana ehab hamed ehab, md (0201000896453, ranaehab015@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

hair regrowth improvement assessed by SALT score and percaentage of hair growth (time frame: 3 months). 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 26 Jan 2026.

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