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

NCT04293822 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-03-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Cetirizine

The patients will be randomly divided into 2 groups; each group contains 30 patients. Patients in both groups will be given the treatment in identical non-labeled bottles with a code and neither the patient nor the doctor will know which treatment is given and what the code referred to. The patients will be instructed to use the treatment twice daily for 6 month duration. This group will use Cetrizine 1% gel, which will be prepared at the department of Pharmaceutics, Faculty of Pharmacy, Assiut University in the form of Nano-transferosomes (NTF).

DRUG

Minoxidil

The patients will be randomly divided into 2 groups; each group contains 30 patients. Patients in both groups will be given the treatment in identical non-labeled bottles with a code and neither the patient nor the doctor will know which treatment is given and what the code referred to. The patients will be instructed to use the treatment twice daily for 6 month duration. This group will use Minoxidil 5% gel

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Sahar Abd-ElMoez · Professor of Dermatology, Venereology and Andrology, Faculty of Medicine, Assiut University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2020-11-30
Completion
2021-11-30

Countries

  • Egypt

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04293822 on ClinicalTrials.gov