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

NCT05369481 | Unknown DMC

• 1 other identifier: Male Androgenic Alopecia
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Androgenic Alopecia

Outcome Measures

Primary Outcomes (1)

• Improvement changes

  improvement will be assessed by comparing the trichoscopic photos before and after treatment as regard hair density

  6 months

Secondary Outcomes (2)

• Patient's satisfaction

  6 months

• Complications

  6 months

Study Arms (2)

Sildenafil 2%

EXPERIMENTAL

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

Drug: Sildenafil 2%

Minoxidil 5 %

EXPERIMENTAL

will receive topical minoxidil 5 % twice daily for 6 months

Drug: Minoxidil 5 %

Interventions

Sildenafil 2% DRUG

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

Also known as: Local Scalp Injection

Sildenafil 2%

Minoxidil 5 % DRUG

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

Also known as: Local Scalp Injection

Minoxidil 5 %

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mohammed Abd El Mawgoud Amer: lead

Study Sites (1)

AL-Azhar University Hospital

Cairo, 11865, Egypt

RECRUITING

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohammed Amer, MD

  Al-Azhar university Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yassir Hagag, MBBCH

CONTACT

+201021121721; yassir_hagag@yahoo.com

Mohammed Amer, MD

CONTACT

+201068682727; Amerrom@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 11, 2022
• Study Start: March 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: September 1, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)