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

NCT04293822 | Unknown Phase 4

• 1 other identifier: AssiutU Dermatology
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (1)

• Change of the hair density (follicles/cm²)

  Improvement of the outcomes of treatment of androgenetic alopecia with Cetirizine 1% gel in comparison to Minoxidil 5% gel in terms of proportion of hair regrowth, the hair density (follicles/cm²) .

  6 months

Secondary Outcomes (1)

• Change of the hair diameter

  6 months

Study Arms (2)

Study group

EXPERIMENTAL

Group of 30 patients randomly selected will use topical Cetirizine 1% gel twice daily over a period of 6 months, where the treatment will be given in identical non-labeled bottles with a code and neither the patients, healthcare provider nor the investigator will know which treatment is given and what the code referred to.

Drug: Cetirizine

Control group

ACTIVE COMPARATOR

Group of 30 patients randomly selected will use topical Minoxil 5% gel twice daily over a period of 6 months, where the treatment will be given in identical non-labeled bottles with a code and neither the patients, healthcare provider nor the investigator will know which treatment is given and what the code referred to.

Drug: Minoxidil

Interventions

Cetirizine DRUG

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).

Also known as: Cetirizine 1% Gel

Study group

Minoxidil DRUG

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

Also known as: Minoxidil 5% Placebo

Control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Only males with Androgenetic Alopecia.
• Age (18 - 50) years.
• AGA grade II to VII according to Norwood-Hamilton classification

You may not qualify if:

• Females with Androgentic Alopecia.
• Previous history of sensitivity to Cetirizine.
• Previous treatment for AGA in the last in the last 3 months
• Chronic Systemic diseases as; hypotension, cardiac patients, renal failure or liver failure.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Alopecia

Interventions

Cetirizine; Gels; Minoxidil

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Piperidines; Pyrimidines

Study Officials

• Sahar Abd-ElMoez

  Professor of Dermatology, Venereology and Andrology, Faculty of Medicine, Assiut University

  STUDY DIRECTOR

Central Study Contacts

Reham A Ibrahim, MBBS

CONTACT

1006033730; dr.rehamabdalla@gmail.com

Aya Y Badran, PhD

CONTACT

1013244819; aya_badran@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: March 3, 2020
• Study Start: June 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2021
• Last Updated: March 4, 2020

Record last verified: 2020-03

Locations

EG (1)