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Status unknownNCT05369481Updated May 11, 2022

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

An interventional study of Sildenafil 2% and Minoxidil 5 % in Androgenic Alopecia, sponsored by Mohammed Abd El Mawgoud Amer. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-11.

Sponsored by Mohammed Abd El Mawgoud Amer · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Androgenic Alopecia
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In context

Alopecia

609 studies on the registry are indexed under Alopecia; 131 are open to participants now.

This study's planned enrollment of 50 is above the median of 45 across 513 interventional studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

This is the only study on the registry with Mohammed Abd El Mawgoud Amer as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Sildenafil 2%

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

    Drug: Sildenafil 2%

  • Experimental
    Minoxidil 5 %

    will receive topical minoxidil 5 % twice daily for 6 months

    Drug: Minoxidil 5 %

Interventions

  • DrugSildenafil 2%

    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

  • DrugMinoxidil 5 %

    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

06

What researchers measure

Primary outcomes

  1. Improvement changes

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

    Time frame: 6 months

Secondary outcomes

  1. 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

    Time frame: 6 months

  2. Complications

    infection and bleeding

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • AL-Azhar University Hospital
    Cairo, 11865, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05369481
Lead sponsor
Mohammed Abd El Mawgoud Amer
Responsible party
Mohammed Abd El Mawgoud Amer (Professor, Al-Azhar University) — Sponsor-investigator
First posted
May 11, 2022
Start date
Mar 1, 2022
Primary completion
Aug 1, 2022 (estimated)
Completion
Sep 1, 2022 (estimated)
Last update
May 11, 2022

Study contacts

Yassir Hagag, MBBCH
Contact
yassir_hagag@yahoo.com
+201021121721
Mohammed Amer, MD
Contact
Amerrom@yahoo.com
+201068682727
Mohammed Amer, MD
principal investigator · Al-Azhar university Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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