Comparison Between Efficacy of Topical Sildenafil 2% and Topical Minoxidil 5% in Treatment of Androgenic Alopecia
Primary Purpose
Androgenic Alopecia
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Sildenafil 2%
Minoxidil 5 %
Sponsored by
About this trial
This is an interventional treatment trial for Androgenic Alopecia
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).
Sites / Locations
- AL-Azhar University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sildenafil 2%
Minoxidil 5 %
Arm Description
will receive topical sildenafil 2% twice daily for 6 months.
will receive topical minoxidil 5 % twice daily for 6 months
Outcomes
Primary Outcome Measures
Improvement changes
improvement will be assessed by comparing the trichoscopic photos before and after treatment as regard hair density
Secondary Outcome Measures
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
Complications
infection and bleeding
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05369481
Brief Title
Comparison Between Efficacy of Topical Sildenafil 2% and Topical Minoxidil 5% in Treatment of Androgenic Alopecia
Official Title
Comparative Study Between the Efficacy of Topical Sildenafil 2% and Topical Minoxidil 5% in the Treatment of Male Androgenic Alopecia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohammed Abd El Mawgoud Amer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenic Alopecia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sildenafil 2%
Arm Type
Experimental
Arm Description
will receive topical sildenafil 2% twice daily for 6 months.
Arm Title
Minoxidil 5 %
Arm Type
Experimental
Arm Description
will receive topical minoxidil 5 % twice daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Sildenafil 2%
Other Intervention Name(s)
Local Scalp Injection
Intervention Description
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
Intervention Name(s)
Minoxidil 5 %
Other Intervention Name(s)
Local Scalp Injection
Intervention Description
Patients with male androgenic alopecia will be given topical Minoxidil 5 % to apply twice daily for 6 consecutive months and then follow up.
Primary Outcome Measure Information:
Title
Improvement changes
Description
improvement will be assessed by comparing the trichoscopic photos before and after treatment as regard hair density
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Patient's satisfaction
Description
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
Title
Complications
Description
infection and bleeding
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yassir Hagag, MBBCH
Phone
+201021121721
Email
yassir_hagag@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed Amer, MD
Phone
+201068682727
Email
Amerrom@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed Amer, MD
Organizational Affiliation
Al-Azhar university Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
AL-Azhar University Hospital
City
Cairo
ZIP/Postal Code
11865
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed Amer, MD
Phone
01068682727
Email
Amerrom@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison Between Efficacy of Topical Sildenafil 2% and Topical Minoxidil 5% in Treatment of Androgenic Alopecia
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