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

NCT06327581 | Recruiting DMC

• 1 other identifier: 101005
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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 (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). 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).

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (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

  3 months

Study Arms (4)

lactic acid group

EXPERIMENTAL

· First group (A): 22 AA patients will be treated with MN combined with lactic acid solution 1%.

Drug: Lactic Acid

vitamin d3

EXPERIMENTAL

· 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)

Drug: vit D

triamcinolone acetonide group

EXPERIMENTAL

· 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

Drug: Triamcinolone Acetonide

saline

EXPERIMENTAL

· Fourth group (D): 22 AA patients will be treated with MN combined with normal saline 0.9%

Drug: Saline

Interventions

Lactic Acid DRUG

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

lactic acid group

vit D DRUG

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)

vitamin d3

Triamcinolone Acetonide DRUG

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

triamcinolone acetonide group

Saline DRUG

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

saline

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: more than 16 years old
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• · 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.

You may not qualify if:

• · 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Rana Ehab

Zagazig, 44519, Egypt

RECRUITING

MeSH Terms

Conditions

Alopecia Areata

Interventions

Lactic Acid; Triamcinolone Acetonide; Sodium Chloride

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Lactates; Hydroxy Acids; Carboxylic Acids; Organic Chemicals; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• rana ehab, md

  Zagazig University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

rana ehab hamed ehab, md

CONTACT

0201000896453; ranaehab015@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of dermatology

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 25, 2024
• Study Start: December 15, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

EG (1)