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

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ClinicalTrials.gov Identifier: NCT04293822
Recruitment Status : Not yet recruiting
First Posted : March 3, 2020
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
Reham Abdalla Ibrahim, Assiut University

Tracking Information
First Submitted Date  ICMJE February 21, 2020
First Posted Date  ICMJE March 3, 2020
Last Update Posted Date March 4, 2020
Estimated Study Start Date  ICMJE June 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2020)
Change of the hair density (follicles/cm²) [ Time Frame: 6 months ]
Improvement of the outcomes of treatment of androgenetic alopecia with Cetirizine 1% gel in comparison to Minoxidil 5% gel in terms of proportion of hair regrowth, the hair density (follicles/cm²) .
Original Primary Outcome Measures  ICMJE
 (submitted: February 29, 2020)
Improvement of the hair density (follicles/cm²) [ Time Frame: 6 months ]
Improvement of the outcomes of treatment of androgenetic alopecia with Cetirizine 1% gel in comparison to Minoxidil 5% gel in terms of proportion of hair regrowth, the hair density (follicles/cm²) .
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2020)
Change of the hair diameter [ Time Frame: 6 months ]
Improvement of the vellus and terminal hair diameter <0.05 mm>
Original Secondary Outcome Measures  ICMJE
 (submitted: February 29, 2020)
Improvement of the hair diameter [ Time Frame: 6 months ]
Improvement of the vellus and terminal hair diameter <0.05 mm>
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Topical Cetirizine 1% vs Minoxidil 5% Gel in Treatment of Androgenetic Alopecia
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
The patients will be randomly divided into 2 groups; each group contains 30 patients. Patients in both groups will be given the treatment in identical non-labeled bottles with a code and neither the patient nor the doctor will know which treatment is given and what the code referred to. The patients will be instructed to use the treatment twice daily for 6 month duration.
Primary Purpose: Treatment
Condition  ICMJE Androgenetic Alopecia
Intervention  ICMJE
  • Drug: Cetirizine

    The patients will be randomly divided into 2 groups; each group contains 30 patients. Patients in both groups will be given the treatment in identical non-labeled bottles with a code and neither the patient nor the doctor will know which treatment is given and what the code referred to. The patients will be instructed to use the treatment twice daily for 6 month duration.

    This group will use Cetrizine 1% gel, which will be prepared at the department of Pharmaceutics, Faculty of Pharmacy, Assiut University in the form of Nano-transferosomes (NTF).

    Other Name: Cetirizine 1% Gel
  • Drug: Minoxidil

    The patients will be randomly divided into 2 groups; each group contains 30 patients. Patients in both groups will be given the treatment in identical non-labeled bottles with a code and neither the patient nor the doctor will know which treatment is given and what the code referred to. The patients will be instructed to use the treatment twice daily for 6 month duration.

    This group will use Minoxidil 5% gel

    Other Name: Minoxidil 5% Placebo
Study Arms  ICMJE
  • Experimental: Study group
    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.
    Intervention: Drug: Cetirizine
  • Active Comparator: Control group
    Group of 30 patients randomly selected will use topical Minoxil 5% 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.
    Intervention: Drug: Minoxidil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 29, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Reham A Ibrahim, MBBS 1006033730 ext +20 dr.rehamabdalla@gmail.com
Contact: Aya Y Badran, PhD 1013244819 ext +20 aya_badran@yahoo.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04293822
Other Study ID Numbers  ICMJE AssiutU Dermatology
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Reham Abdalla Ibrahim, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sahar Abd-ElMoez Professor of Dermatology, Venereology and Andrology, Faculty of Medicine, Assiut University
PRS Account Assiut University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP