Topical Cetirizine in Androgenetic Alopecia in Females

NCT04481412 | Completed Phase 2

• 1 other identifier: Cetirizine in alopecia
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Androgenetic Alopecia

Keywords

cetirizine; minoxidil; androgenetic alopecia (AGA); Female pattern hair loss (FPHL)

Outcome Measures

Primary Outcomes (4)

• The change from baseline in number of terminal hairs and vellus hair

  Trichoscopic evaluation: of frontal, occipital and temporal areas regarding the change from baseline in number of terminal hairs, growing hair and vellus hair.

  baseline, 12, 24 weeks

• The change from baseline in hair shaft thickness

  Trichoscopic evaluation: of frontal, occipital and temporal areas regarding the change from baseline in hair shaft thickness.

  baseline, 12, 24 weeks

• The change from baseline in terminal and vellus hair density

  Trichoscopic evaluation: of frontal, occipital and temporal areas regarding the change from baseline in number of follicular openings.

  baseline, 12, 24 weeks

• The change in patient self-assessment from baseline

  Patient self-assessment of hair growth will be determined by means of a set of predetermined 5 questions in Arabic, each of which asks the patient about a specific aspect of their hair compared with the start of the study.

  baseline, 6, 12, 18, 24 weeks

Secondary Outcomes (2)

• The change in hair growth from baseline using global photographic assessment

  baseline, 12, 24 weeks

• Number of patients with adverse effects

  6, 12, 18, 24 weeks

Study Arms (2)

Study group

EXPERIMENTAL

(33) patients will apply topical minoxidil (5%) once daily and topical cetirizine (1%) once daily on their scalp for 6 months.

Drug: Topical cetirizine; Drug: Topical minoxidil

Control group

ACTIVE COMPARATOR

(33) patients will apply topical minoxidil (5%) once daily and placebo once daily on their scalp for 6 months.

Drug: Placebo; Drug: Topical minoxidil

Interventions

Topical cetirizine DRUG

Topical cetirizine 1% spray that will be prepared at Faculty of Pharmacy, Cairo University and will be applied once daily.

Also known as: Cetirizine 1%

Study group

Placebo DRUG

96% ethanol that will be applied once daily.

Also known as: 96% ethanol

Control group

Topical minoxidil DRUG

Topical Minoxidil 5% that will be applied once daily.

Also known as: Minoxidil 5%

Control group; Study group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: Females with androgenetic alopecia of age 20-50.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females with androgenetic alopecia of age 20-50 years.
• Patients experiencing active hair loss within the last 12 months.
• Sinclair scale 2, 3 and 4.
• Patients willing to continue their current regimen of vitamins and nutritional supplements and not start any new vitamins or nutritional supplements for the duration of the study.
• Patients willing to use a mild non-medicated shampoo and conditioner for the duration of the study.
• Patients who did not receive topical or systemic treatment for androgenetic alopecia or prostaglandins in the last 6 months.

You may not qualify if:

• \. Patients with a chronic dermatological condition (eczema, psoriasis, infection, etc) of the scalp other than FPHL.
• \. Subjects who had hair transplants, scalp reduction, current hair weave or tattooing in the target area, which makes it difficult to perform hair count assessment.
• \. Subjects who received radiation therapy to the scalp, or has had chemotherapy in the past year.
• \. Subjects who have a known underlying medical problem that could influence hair growth such as HIV infection, connective tissue disease, a thyroid condition, inflammatory bowel disease or other medical conditions, at the discretion of the investigator.
• \. Subjects with clinical diagnosis of alopecia areata or other non-AGA forms of alopecia.
• \. Pregnant or lactating females or planning to become pregnant for the duration of the study.
• \. Patients with severe cardiovascular disease, uncontrolled or untreated hypertension, arrythmia or clinically relevant hypotension.
• \. Subjects with hair loss for greater than 5 years, as medical therapy is unlikely to have much effect at restoring hair follicles inactive for that long of a period.
• \. The subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles.
• \. Patients using any medications that potentially cause drug-induced hair loss (e.g., depotestosterone, haloperidol, methotrexate, methylprednisolone, prednisone, testosterone, divalproex sodium) within the last 3 months.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Al-Kasr Al-Ainy outpatient dermatology clinic

Cairo, ِAl-Kasr Al-Ainy, 11559, Egypt

Location

Related Publications (4)

• Jaworsky C, Kligman AM, Murphy GF. Characterization of inflammatory infiltrates in male pattern alopecia: implications for pathogenesis. Br J Dermatol. 1992 Sep;127(3):239-46. doi: 10.1111/j.1365-2133.1992.tb00121.x.

  PMID: 1390168 BACKGROUND

• Guo H, Gao WV, Endo H, McElwee KJ. Experimental and early investigational drugs for androgenetic alopecia. Expert Opin Investig Drugs. 2017 Aug;26(8):917-932. doi: 10.1080/13543784.2017.1353598. Epub 2017 Jul 12.

  PMID: 28689433 BACKGROUND

• Rossi A, Campo D, Fortuna MC, Garelli V, Pranteda G, De Vita G, Sorriso-Valvo L, Di Nunno D, Carlesimo M. A preliminary study on topical cetirizine in the therapeutic management of androgenetic alopecia. J Dermatolog Treat. 2018 Mar;29(2):149-151. doi: 10.1080/09546634.2017.1341610. Epub 2017 Jun 29.

  PMID: 28604133 BACKGROUND

• Bassiouny EA, El-Samanoudy SI, Abbassi MM, Nada HR, Farid SF. Comparison between topical cetirizine with minoxidil versus topical placebo with minoxidil in female androgenetic alopecia: a randomized, double-blind, placebo-controlled study. Arch Dermatol Res. 2023 Jul;315(5):1293-1304. doi: 10.1007/s00403-022-02512-2. Epub 2022 Dec 26.

  PMID: 36571611 DERIVED

MeSH Terms

Conditions

Alopecia

Interventions

Cetirizine; Ethanol; 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; Alcohols; Organic Chemicals; Piperidines; Pyrimidines

Study Officials

• Maggie Abbassi, PhD

  Faculty of Pharmacy, Cairo University

  STUDY CHAIR

• Hanan Nada, PhD

  Cairo University

  STUDY CHAIR

• Samar Farid, PhD

  Faculty of Pharmacy, Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head and professor of clinical pharmacy department

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 22, 2020
• Study Start: July 25, 2020
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)