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

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Brief Title

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

Official Title

Topical Cetirizine Gel Versus Minoxidil 5% Gel in Treatment of Androgenetic Alopecia

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.
    

Detailed Description

      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.

      Hair loss typically begins with bi-temporal recession of the frontal hairline, followed by
      diffuse hair thinning at the vertex, and eventual complete loss of hair at the center of the
      vertex. The bald patch at the vertex subsequently joins the frontal receding hairline,
      leaving an island of hair on the frontal scalp, which finally disappears leaving hair only in
      the parietal and occipital zones producing the characteristic "horseshoe" pattern.

      Androgenetic alopecia is classified according to the Hamilton-Norwood scale into grades (from
      I to VII).

      AGA features a progressive miniaturization of the hair follicle leading to vellus
      transformation of terminal hair which results from an alteration in hair cycle dynamics:
      anagen phase duration gradually decreases and that of the telogen phase increases. As the
      anagen phase duration determines hair length, the new anagen hair becomes shorter, eventually
      leading to bald appearance.

      The etiology of AGA is multifactorial and polygenetic. Male AGA (MAGA) is clearly an
      androgen-dependent condition and, although the mode of inheritance is uncertain, a genetic
      predisposition is observed, while in female AGA (FAGA) the role of androgens is still
      uncertain.

      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.

      Finasteride is a type 2 5α-reductase inhibitor that decreases the conversion of testosterone
      to dihydrotestosterone (DHT), which is responsible for the miniaturization of the hair
      follicle seen in MAGA.

      Minoxidil is a direct arteriolar vasodilator acts by opening potassium channels. Unwanted
      hair growth was observed as an adverse effect in 24-100 % of patients treated by Minoxidil
      for hypertension. Minoxidil 2 % solution was approved in 1988, while the 5 % solution was
      approved in 1991, and the 5 % foam in 2016 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.

      Their action is variable depending on the class they belong to: PGE and PGF2a play a
      generally positive role on the hair growth, while PGD2 an inhibitory role on the hair growth.

      Multiple studies had claimed that prostaglandins are deregulated in both alopecia areata (AA)
      and AGA.

      Garza in 2012 found elevated levels of prostaglandin D2 synthase (PTGDS) at the mRNA and
      protein levels in bald scalp versus haired scalp of men with AGA. Also found that the
      enzymatic product of PTGDS and prostaglandin D2 (PGD2) are raised in bald human scalp tissue.
      These results implicate that PGD2 might has a role in pathogenesis of AGA, thus suggest new
      receptor targets for its treatment.

      Cetirizine, the active carboxylic acid metabolite of hydroxyzine, is a safe and selective
      second-generation histamine H1 receptor antagonist widely used in daily practice. It has
      anti-inflammatory properties and high specific affinity for histamine H1 receptors. Studies
      have shown cetirizine causes a significant reduction in both the inflammatory cell infiltrate
      and PGD2 production, and these effects are not related to its anti-H1 activity.

      The oral administration of cetirizine is commonly leads to different systemic side effects as
      sedation, ocular dryness, tiredness and dry mouth. Thus, the topical formulation for
      cetirizine is expected to be a rational and 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.

      As the stratum corneum is the main barrier for the effective topical drug application,
      numerous attempts have been made to enhance topical drug delivery such as lipid nanocarriers
      (nano-transferosomes (NTF), follicular penetration, microbubbles and microneedles.

      Rossi in 2018 evaluated for the first time in literature the tolerability and efficacy of
      topical cetirizine 1% lotion inpatients with AGA and claimed that topical cetirizine causes a
      significant improvement of the initial framework of AGA in both males and females and
      recommended further studies to allow better investigation for the role of cetirizine in AGA.

      To the best of the investigators knowledge the use of topical cetirizine 1% gel has not yet
      been tried in the therapeutic management of Egyptian males with AGA.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Change of the hair density (follicles/cm²)

Secondary Outcome

 Change of the hair diameter

Condition

Androgenetic Alopecia

Intervention

Cetirizine

Study Arms / Comparison Groups

 Study group
Description:  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.

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

June 2020

Completion Date

November 2021

Primary Completion Date

November 2020

Eligibility Criteria

        Inclusion Criteria:

          1. Only males with Androgenetic Alopecia.

          2. Age (18 - 50) years.

          3. AGA grade II to VII according to Norwood-Hamilton classification

        Exclusion Criteria:

          1. Females with Androgentic Alopecia.

          2. Previous history of sensitivity to Cetirizine.

          3. Previous treatment for AGA in the last in the last 3 months

          4. Chronic Systemic diseases as; hypotension, cardiac patients, renal failure or liver
             failure.
      

Gender

Male

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

No

Contacts

Sahar Abd-ElMoez, 1006033730, [email protected]

Location Countries

Egypt

Location Countries

Egypt

Administrative Informations


NCT ID

NCT04293822

Organization ID

AssiutU Dermatology


Responsible Party

Principal Investigator

Study Sponsor

Assiut University


Study Sponsor

Sahar Abd-ElMoez, Study Director, Professor of Dermatology, Venereology and Andrology, Faculty of Medicine, Assiut University


Verification Date

March 2020