Comparison Between Efficacy of Topical Sildenafil 2% and Topical Minoxidil 5% in Treatment of Androgenic Alopecia

NCT ID: NCT05369481

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-09-01

Brief Summary

Androgenetic alopecia (AGA) is hair loss with specific clinical pattern, It Is characterized by follicular miniaturization, which occurs due to systemic androgens and genetic factors. Prevalence differs according to ethnic groups. It is more common and more severe in white men than in Asian and black men. The incidence increases with age. According to Hamilton's study, the prevalence is 30% in men at the age of 30, and 50% in the age of 50. Generally, the age of onset is the 3rd and 4th decade.

Detailed Description

Androgenetic alopecia may affect self-esteem and quality of life in several affected individuals. There are two FDA-approved drugs for pattern baldness: topical minoxidil and finasteride, both of which require at least a 4- to 6-month trial before noticing improvement and must be used indefinitely to maintain a response. As such, medication adherence often can be poor. Furthermore, initiation of the drug may cause an initial shedding phase.

Minoxidil was the first and, so far, the only topical product that has been FDA approved for the treatment of AGA. Minoxidil was originally developed as an oral medication for hypertension. Hypertrichosis was found in 24-100 % of patients treated with oral minoxidil, which led to the treatment of AGA with topical minoxidil.

Androgenic Alopecia is caused by the overproduction of 5αdihydrotestosterone (5α-DHT), a potent androgen within the hair follicle, specifically the dermal papilla (DP) cells that are the main regulators of hair growth and are the only site of 5α-DHT action.

Sildenafil is a selective inhibitor of phosphodiesterase 5 and was originally developed as an anti-anginal drug due to its vasodilatory and antiplatelet coagulation properties. Sildenafil enhances the proliferation of human dermal papilla cells and up-regulates the mRNA expression of vascular endothelial growth factor and platelet-derived growth factor (PDGF) which are responsible for hair growth.

Topical sildenafil 1% has been used in the treatment of male androgenic alopecia.

Conditions

Androgenic Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sildenafil 2%

will receive topical sildenafil 2% twice daily for 6 months.

Group Type: EXPERIMENTAL

Sildenafil 2%

Intervention Type: DRUG

Patients with male androgenic alopecia will be given topical Sildenafil 2% to apply twice daily for 6 consecutive months and then follow up.

Minoxidil 5 %

will receive topical minoxidil 5 % twice daily for 6 months

Group Type: EXPERIMENTAL

Minoxidil 5 %

Intervention Type: DRUG

Patients with male androgenic alopecia will be given topical Minoxidil 5 % to apply twice daily for 6 consecutive months and then follow up.

Interventions

Sildenafil 2%

Patients with male androgenic alopecia will be given topical Sildenafil 2% to apply twice daily for 6 consecutive months and then follow up.

Intervention Type: DRUG

Minoxidil 5 %

Patients with male androgenic alopecia will be given topical Minoxidil 5 % to apply twice daily for 6 consecutive months and then follow up.

Intervention Type: DRUG

Other Intervention Names

Local Scalp Injection; Local Scalp Injection

Eligibility Criteria

Inclusion Criteria

• Subjects clinically and dermoscopic diagnosed with AGA.
• Age ranges from 18 to 45 years old.
• Males
• Willingness to provide pictures and follow-up studies.

Exclusion Criteria

• Patients who received any topical or systemic treatment for AGA during the last 6 months,
• Patients who had other types of alopecia such as alopecia areata, alopecia totalis, telogen effluvium, anagen effluvium, and acquired cicatricial alopecia.
• Patients with anemia, thyroid disease, and vitamin D deficiency,
• Any autoimmune disease or chronic debilitating disease (chronic renal failure, congestive heart failure, hepatic patients, cancer patients).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mohammed Abd El Mawgoud Amer

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Abd El Mawgoud Amer

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mohammed Amer, MD

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar university Hospital

Locations

AL-Azhar University Hospital

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Yassir Hagag, MBBCH

Role: CONTACT

yassir_hagag@yahoo.com

+201021121721

Mohammed Amer, MD

Role: CONTACT

Amerrom@yahoo.com

+201068682727

Facility Contacts

Mohammed Amer, MD

Role: primary

Amerrom@yahoo.com

01068682727

Other Identifiers

Male Androgenic Alopecia

Identifier Type: -

Identifier Source: org_study_id