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
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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 |
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Androgenetic Alopecia | Drug: Cetirizine Drug: Minoxidil | Phase 4 |

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 |

Arm | Intervention/treatment |
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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.
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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.
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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 |
- 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) .
- Change of the hair diameter [ Time Frame: 6 months ]Improvement of the vellus and terminal hair diameter <0.05 mm>

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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 |
Inclusion Criteria:
- Only males with Androgenetic Alopecia.
- Age (18 - 50) years.
- AGA grade II to VII according to Norwood-Hamilton classification
Exclusion Criteria:
- Females with Androgentic Alopecia.
- Previous history of sensitivity to Cetirizine.
- Previous treatment for AGA in the last in the last 3 months
- Chronic Systemic diseases as; hypotension, cardiac patients, renal failure or liver failure.

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
Contact: Reham A Ibrahim, MBBS | 1006033730 ext +20 | dr.rehamabdalla@gmail.com | |
Contact: Aya Y Badran, PhD | 1013244819 ext +20 | aya_badran@yahoo.com |
Egypt | |
Assiut University | |
Assiut, Egypt, 71515 |
Study Director: | Sahar Abd-ElMoez | Professor of Dermatology, Venereology and Andrology, Faculty of Medicine, Assiut University |
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 |
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 |
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 |