drugset / Trial / NCT04293822

Topical Cetirizine 1% vs Minoxidil 5% Gel in Treatment of Androgenetic Alopecia

NCT04293822

Phase 4 Unknown 60 enrolled Assiut University
RandomizedParallel-groupTriple-blindTreatment

Summary

Androgenetic alopecia (AGA), also known as androgenic alopecia or male pattern baldness, is the most common type of progressive hair loss. It is a polygenetic condition with variable degree of severity, age of onset, and location of hair loss. Male AGA (MAGA) is clearly an androgen-dependent condition and, although the mode of inheritance is uncertain, a genetic predisposition is observed. Regarding treatment of AGA; in most cases it's challenging and unsatisfactory. Finasteride and Minoxidil 2-5 % solution are the only US Food and Drug Administration (FDA) approved treatment options for MAGA. On the basis of hypertrichosis observed in patients treated with analogues of prostaglandin PGF2a (i.e. latanoprost used for glaucoma), it was supposed that prostaglandins would have an important role in the hair growth (Nieves et al., 2014). Multiple studies had claimed that prostaglandins are deregulated in both alopecia areata (AA) and AGA. Cetirizine, is a safe and selective second-generation histamine H1 receptor antagonist widely used. It has anti-inflammatory properties. Studies have shown cetirizine causes a significant reduction in both the inflammatory cell infiltrate and PGD2 production. The oral administration of cetirizine is commonly leads to different systemic side effects. Thus the topical formulation is expected to be an effective tool for avoiding the oral side effects as well as better targeting, but unfortunately, no topical formulation of cetirizine is available in the market till date.

Timeline

Start
2020-06
Primary completion
2020-11
Completion
2021-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetirizine Other / unclassified 1 % Topical
Comparator Minoxidil Small molecule 5 % Topical

Indications