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Completed

NCT Number: NCT07757867

Microneedling-Assisted Delivery of Cetirizine Versus Latanoprost in Alopecia Areata

This study planned to measure the effectiveness and safety of microneedling aided administration of cetirizine 1% versus latanoprost 0.01% in alopecia areata.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia Governorate, Egypt, 31527, Egypt

About this study

Alopecia areata (AA) is a chronic inflammatory disease affecting the hair follicles with a possible multifactorial origin, most prominently in genetically predisposed patients. It is a common cause of non scarring hair loss that presents in a patchy, confluent, or diffuse pattern. The onset may be at any age and there is no known race or sex preponderance.

The treatment of AA depends on the severity and extent of the disease. Treatment options include topical or intralesional corticosteroids, phototherapy, topical irritants, topical minoxidil, topical tacrolimus, topical vitamin D analogs and platelet rich plasma injection. For resistant cases, psoralen with ultraviolet A light, oral cyclosporine and other immunosuppressants could be beneficial.

Microneedling therapy is becoming popular in management of acne scars and also for facial rejuvenations. Recently it has been shown to stimulate hair growth. The proposed mechanism of action is thought to be stimulation of dermal papilla and stem cells and also increasing the blood supply to the hair follicles.

Scalp microneedling is a minimally invasive procedure in which various micro-channels are created by short fine needles to help in penetration and absorption of various agents into the skin. So, microneedling is a promising and effective therapy for the treatment of AA

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newly diagnosed cases of alopecia areata.
  • Patients of any age.
  • Both male and female patients.
  • Recent-onset patchy alopecia areata of ≤6 months' duration.
  • Presence of no more than two alopecia patches.
  • Stationary course of the disease.
  • Willingness to participate in the study.
  • Provision of written informed consent or parental/guardian consent for minors.

Exclusion criteria

  • Extensive alopecia areata, including alopecia totalis or alopecia universalis.
  • Previous treatment of the alopecia areata lesions.
  • Active scalp infection.
  • Presence of associated dermatological, systemic, or autoimmune comorbidities.
  • Known allergy or hypersensitivity to any of the planned therapeutic agents.

Treatment and study plan

Cetirizine (Zyrtec)

Drug

Patinets treated with microneedling-aided administration of topical cetirizine 1% solution

latanoprost

Drug

Patients treated with microneedling-aided administration of topical triamcinolone acetonide (TrA) (10mg/ml) as a positive control group

Triamcinolone Acetonide

Drug

Patients treated with microneedling-aided administration of topical triamcinolone acetonide (TrA) (10mg/ml) as a positive control group

Microneedling only

Procedure

Patientstreated with microneedling only as a negative control group

Primary outcomes

  1. Severity of Alopecia Tool Score (SALT Score)

    Time frame: Baseline and 12 weeks

    The Severity of Alopecia Tool (SALT) score was used to assess the extent of scalp hair loss. The score ranges from 0 to 100, with higher scores indicating greater scalp hair loss. Changes in SALT score from baseline was compared between the treatment groups.

Secondary outcomes

  1. Global assessment of hair regrowth

    Time frame: Baseline and at the end of the 12-week treatment period

    Hair regrowth was evaluated by the investigator using standardized clinical photographs and a global assessment scale. The degree of hair regrowth was graded on a 5-point scale ranging from 0 (no regrowth) to 4 (excellent regrowth, ≥75%), with higher scores indicating greater clinical improvement. Assessments were performed at baseline and at the end of the 12-week treatment period.

  2. Adverse events

    Time frame: Throughout the 12-week study period.

    Complications, including pain, erythema, edema, pruritus, infection, post-inflammatory hyperpigmentation, allergic reactions, and any other local or systemic adverse events

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Microneedling-Assisted Delivery of Cetirizine Versus Latanoprost in Alopecia Areata: A Pilot Randomized Controlled Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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