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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Drug: Cetirizine Drug: Minoxidil Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Official Title: Topical Cetirizine Gel Versus Minoxidil 5% Gel in Treatment of Androgenetic Alopecia
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

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.
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




Primary Outcome Measures :
  1. 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) .


Secondary Outcome Measures :
  1. Change of the hair diameter [ Time Frame: 6 months ]
    Improvement of the vellus and terminal hair diameter <0.05 mm>



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04293822


Contacts
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Contact: Reham A Ibrahim, MBBS 1006033730 ext +20 dr.rehamabdalla@gmail.com
Contact: Aya Y Badran, PhD 1013244819 ext +20 aya_badran@yahoo.com

Locations
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Egypt
Assiut University
Assiut, Egypt, 71515
Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Sahar Abd-ElMoez Professor of Dermatology, Venereology and Andrology, Faculty of Medicine, Assiut University
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Responsible Party: Reham Abdalla Ibrahim, Doctor, Assiut University
ClinicalTrials.gov Identifier: NCT04293822    
Other Study ID Numbers: AssiutU Dermatology
First Posted: March 3, 2020    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020

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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
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Cetirizine
Minoxidil
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Vasodilator Agents