Topical Cetirizine in Androgenetic Alopecia in Females

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cairo University
• Treatments: Cetirizine; Ethanol; Minoxidil

Criteria

Inclusion Criteria:

1. Females with androgenetic alopecia of age 20-50 years.

2. Patients experiencing active hair loss within the last 12 months.

3. Sinclair scale 2 and 3.

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.

5. Patients willing to use a mild non-medicated shampoo and conditioner for the duration of the study.

6. Patients who did not receive topical or systemic treatment for androgenetic alopecia or prostaglandins in the last 6 months.

Exclusion Criteria:

• 1. Patients with a chronic dermatological condition (eczema, psoriasis, infection, etc) of the scalp other than FPHL.

2. 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.

3. Subjects who received radiation therapy to the scalp, or has had chemotherapy in the past year.

4. 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.

5. Subjects with clinical diagnosis of alopecia areata or other non-AGA forms of alopecia.

6. Pregnant or lactating females or planning to become pregnant for the duration of the study.

7. Patients with severe cardiovascular disease, uncontrolled or untreated hypertension, arrythmia or clinically relevant hypotension.

8. 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.

9. The subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles.

10. 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.