Topical Cetirizine in Androgenetic Alopecia in Females
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Intervention name(s): Topical cetirizine; Placebo; Topical minoxidil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Topical cetirizine 1% spray that will be prepared at Faculty of Pharmacy, Cairo University and will be applied once daily.; 96% ethanol that will be applied once daily.; Topical Minoxidil 5% that will be applied once daily.
Other intervention name(s): Cetirizine 1%; 96% ethanol; Minoxidil 5%
Intervention MeSH terms: Cetirizine; Ethanol; Minoxidil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cetirizine; minoxidil; androgenetic alopecia (AGA); Female pattern hair loss (FPHL)