Topical Cetirizine in Androgenetic Alopecia in Females

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Brief Title

Topical Cetirizine in Androgenetic Alopecia in Females

Official Title

The Role of Cetirizine in Androgenetic Alopecia in Females

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.
    

Detailed Description

      Androgenetic alopecia (AGA) is the most common form of alopecia in men and women. It is a
      hereditary, androgen-dependent, progressive thinning of scalp hair that follows a defined
      pattern. The disease mechanism is still relatively poorly understood, but involves a strong
      genetic contribution as well as some environmental input. AGA manifests as a noticeable
      reduction of scalp hair coverage, shorter miniaturized telogen vellus hair follicles, and
      significantly slower rates of hair growth. Approximately 6% to 38% of healthy women
      experience some degree of frontal and frontoparietal hair loss. AGA may have significant
      impact on quality of life in female patients. When female AGA is associated with high levels
      of androgens, systemic antiandrogenic therapy may be needed. However, treating it with oral
      antiandrogens is usually ineffective suggesting that most female AGA cases are not systemic
      androgen dependent and topical treatment may be more appropriate.

      Currently, the only clinically validated and licensed medication approved for increasing hair
      density in women with AGA is 2 % minoxidil topical solution, and up to 5% minoxidil in
      several countries. The collective effects of minoxidil lead to increased cutaneous blood
      flow, prolongation of the anagen growth phase, and increase in the size of smaller hair
      follicles. However, it produces moderate results, and must continue to be used to have a
      continued benefit, and may produce adverse side effects. The use of higher concentrations of
      minoxidil in women is supported by results from an early study suggesting that concentrations
      higher than 2% could improve efficacy without increasing the rates of adverse events when
      applying not more than 60 mg of minoxidil per day.

      Based on the hypertrichosis observed in patients treated with analogues of prostaglandin F2a
      (PGF2a) (i.e. latanoprost used for glaucoma), it was supposed that prostaglandins would have
      an important role in hair growth. Their action is variable depending on the class they belong
      to: prostaglandin E(PGE) and PGF2a play a generally positive role on the hair growth, while
      PGD2 has an inhibitory role on the hair growth. Elevated levels of prostaglandin D2 synthase
      (PGDS) were found at the messenger ribonucleic acid (mRNA) and protein levels in bald scalp
      versus haired scalp of men with AGA; as well as the enzymatic product of PGDS, (PGD2), is
      generally elevated in bald human scalp tissue.

      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. However, these effects
      apparently are not related to its anti-H1 activity. 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 (which often cause of hypertrichosis, contact allergic dermatitis, headache and
      hypotension), 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.
    

Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 The change in hair growth from baseline using global photographic assessment

Condition

Androgenetic Alopecia

Intervention

Topical cetirizine

Study Arms / Comparison Groups

 Study group
Description:  (30) patients will apply topical minoxidil (5%) once daily and topical cetirizine (1%) once daily on their scalp for 6 months.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

60

Start Date

February 16, 2020

Completion Date

December 2021

Primary Completion Date

November 2021

Eligibility 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.
      

Gender

Female

Ages

20 Years - 50 Years

Accepts Healthy Volunteers

No

Contacts

Maggie Abbassi, PhD, 00201061500242, [email protected]

Location Countries

Egypt

Location Countries

Egypt

Administrative Informations


NCT ID

NCT04481412

Organization ID

Cetirizine in alopecia


Responsible Party

Principal Investigator

Study Sponsor

Cairo University


Study Sponsor

Maggie Abbassi, PhD, Study Chair, Faculty of Pharmacy, Cairo University


Verification Date

July 2020