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

Comparative Study Between the Efficacy of Topical Sildenafil 2% and Topical Minoxidil 5% in the Treatment of Male Androgenic Alopecia

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.

Study Overview

• Status: Recruiting
• Conditions: Androgenic Alopecia
• Intervention / Treatment: Drug: Sildenafil 2%; Drug: Minoxidil 5 %

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yassir Hagag, MBBCH; Phone Number: +201021121721; Email: yassir_hagag@yahoo.com
• Study Contact Backup: Name: Mohammed Amer, MD; Phone Number: +201068682727; Email: Amerrom@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt, 11865
    • Recruiting
    • Al-Azhar University hospital
    • Contact: Mohammed Amer, MD; Phone Number: 01068682727; Email: Amerrom@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sildenafil 2%; will receive topical sildenafil 2% twice daily for 6 months.	Drug: 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.; Other Names: Local Scalp Injection
Experimental: Minoxidil 5 %; will receive topical minoxidil 5 % twice daily for 6 months	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.; Other Names: Local Scalp Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement changes	improvement will be assessed by comparing the trichoscopic photos before and after treatment as regard hair density	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's satisfaction	by asking the patients and changes in dermatology life Quality Index score as it reflects the quality of life related to skin manifestations	6 months
Complications	infection and bleeding	6 months

Collaborators and Investigators

• Sponsor: Mohammed Abd El Mawgoud Amer
• Investigators: Principal Investigator: Mohammed Amer, MD, Al-Azhar University hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: May 6, 2022
• First Submitted That Met QC Criteria: May 9, 2022
• First Posted (Actual): May 11, 2022

Study Record Updates

• Last Update Posted (Actual): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Minoxidil
• Other Study ID Numbers: Male Androgenic Alopecia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No