NCT04481412

Topical Cetirizine in Androgenetic Alopecia in Females

Completed Phase 2, PHASE3 Last updated 8 February 2023

What this trial tests

Phase 2, PHASE3 trial testing Topical cetirizine in Androgenetic Alopecia in 66 participants. Completed in 30 November 2021.

Timeline

25 July 2020

Primary endpoint
30 November 2021

30 November 2021

Quick facts

Lead sponsor	Cairo University
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	66
Start date	25 July 2020
Primary completion	30 November 2021
Estimated completion	30 November 2021
Sites	1 location across Egypt

Drugs / interventions tested

• Topical cetirizine — full drug profile →
• Placebo
• Topical minoxidil — full drug profile →

Conditions studied

• Androgenetic Alopecia — all drugs for Androgenetic Alopecia →

Sponsor

Cairo University

Who can join

Adults 20 to 50, female only, with Androgenetic Alopecia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cetirizine is a safe and selective, second-generation histamine H1 receptor antagonist, widely used in daily practice. A study showed that cetirizine causes a significant reduction in both the inflammatory cell infiltrate and PGD2 production. A pilot study on topical cetirizine showed that cetirizine increased total hair density, terminal hair density and diameter. Also, its lower potential side effects if compared with other drugs commonly used for AGA, as minoxidil, can promote a wider use and better compliance of cetirizine in the future for the treatment of AGA. Combinations of therapies are likely to be more efficacious than single treatments.

Treatments to clinically improve scalp hair density and reduce mid-pattern thinning leading to improved scalp coverage are highly important for the affected women. On the basis of the above evidence and lacking studies that confirm the effectiveness of cetirizine in AGA treatment, the aim of this study is to evaluate the efficacy and tolerability of topical cetirizine in female patients with AGA.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Innovative Strategies for Hair Regrowth and Skin Visualization.
   Mai Q, Han Y, Cheng G, Ma R, et al · · 2023 · cited 9× · PMID 37111686 · DOI 10.3390/pharmaceutics15041201
2. Comparison between topical cetirizine with minoxidil versus topical placebo with minoxidil in female androgenetic alopecia: a randomized, double-blind, placebo-controlled study.
   Bassiouny EA, El-Samanoudy SI, Abbassi MM, Nada HR, et al · · 2023 · cited 6× · PMID 36571611 · DOI 10.1007/s00403-022-02512-2
3. Repurposing of H₁-receptor antagonists (levo)cetirizine, (des)loratadine, and fexofenadine as a case study for systematic analysis of trials on clinicaltrials.gov using semi-automated processes with custom-coded software.
   Specht T, Seifert R. · · 2024 · cited 5× · PMID 37870580 · DOI 10.1007/s00210-023-02796-9