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

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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

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.
    


Study Type

Interventional


Primary Outcome

Improvement changes

Secondary Outcome

 Patient's satisfaction

Condition

Androgenic Alopecia

Intervention

Sildenafil 2%

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

50

Start Date

March 1, 2022

Completion Date

September 1, 2022

Primary Completion Date

August 1, 2022

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).
      

Gender

All

Ages

18 Years - 45 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Mohammed Amer, MD, +201021121721, [email protected]

Location Countries

Egypt

Location Countries

Egypt

Administrative Informations


NCT ID

NCT05369481

Organization ID

Male Androgenic Alopecia


Responsible Party

Sponsor-Investigator

Study Sponsor

Mohammed Abd El Mawgoud Amer


Study Sponsor

Mohammed Amer, MD, Principal Investigator, Al-Azhar university Hospital


Verification Date

May 2022