NCT07757867

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

2 years

First QC Date

August 6, 2026

Last Update Submit

August 6, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Severity of Alopecia Tool Score (SALT Score)

    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.

    Baseline and 12 weeks

Secondary Outcomes (2)

  • Global assessment of hair regrowth

    Baseline and at the end of the 12-week treatment period

  • Adverse events

    Throughout the 12-week study period.

Study Arms (4)

Group A

EXPERIMENTAL

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

Drug: Cetirizine (Zyrtec)

Group B

EXPERIMENTAL

Patients treated with microneedling-aided administration of topical latanoprost 0.01% solution.

Drug: Latanoprost

group C

ACTIVE COMPARATOR

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

Drug: Triamcinolone Acetonide

Group D

ACTIVE COMPARATOR

Patients treated with microneedling only as a negative control group

Procedure: Microneedling only

Interventions

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

Group A

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

Group B

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

group C

Patientstreated with microneedling only as a negative control group

Group D

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

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

Location

MeSH Terms

Conditions

Alopecia Areata

Interventions

CetirizineLatanoprostTriamcinolone Acetonide

Condition Hierarchy (Ancestors)

AlopeciaHypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

HydroxyzinePiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsTriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Dermatology and Venereology

Study Record Dates

First Submitted

August 6, 2026

First Posted

August 11, 2026

Study Start

October 1, 2022

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

August 11, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.

Locations