Androgenic AlopeciaNCT05369481
Comparison Between Efficacy of Topical Sildenafil 2% and Topical Minoxidil 5% in Treatment of Androgenic Alopecia
A study testing Sildenafil 2% and Minoxidil 5 % in people with Androgenic Alopecia, run by Mohammed Abd El Mawgoud Amer at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Androgenic Alopecia
- What is being tested?
- Sildenafil 2% and Minoxidil 5 %
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects clinically and dermoscopic diagnosed with AGA.
- Age ranges from 18 to 45 years old.
- Males
- Willingness to provide pictures and follow-up studies.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
AL-Azhar University Hospital
Cairo, 11865
Mohammed Amer, MD, 01068682727, Amerrom@yahoo.com
About this study
Official title: 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.
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.
- Conditions
- Androgenic Alopecia
- Being tested
- Sildenafil 2%, Minoxidil 5 %
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil 2%Drug
Also called Local Scalp Injection
Patients with male androgenic alopecia will be given topical Sildenafil 2% to apply twice daily for 6 consecutive months and then follow up.
Minoxidil 5 %Drug
Also called Local Scalp Injection
Patients with male androgenic alopecia will be given topical Minoxidil 5 % to apply twice daily for 6 consecutive months and then follow up.
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil 2% | Experimental | will receive topical sildenafil 2% twice daily for 6 months. Receives: Drug: Sildenafil 2% |
| Minoxidil 5 % | Experimental | will receive topical minoxidil 5 % twice daily for 6 months Receives: Drug: Minoxidil 5 % |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement changes
improvement will be assessed by comparing the trichoscopic photos before and after treatment as regard hair density
Measured: 6 months
Secondary outcomes (2)
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
Measured: 6 months
Complications
infection and bleeding
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start1 Mar 2022
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohammed Abd El Mawgoud Amer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohammed Abd El Mawgoud Amer, Al-Azhar University
- Investigators
- Mohammed Amer, MD, Principal investigator, Al-Azhar university Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369481
- Sponsor's protocol ID
- Male Androgenic Alopecia
- Status last verified
- May 2022
- First submitted
- 6 May 2022
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between the Efficacy of Topical Sildenafil 2% and Topical Minoxidil 5% in the Treatment of Male Androgenic Alopecia
- ClinicalTrials.gov ID
- NCT05369481
- Acronym / sponsor ID
- Male Androgenic Alopecia
- Conditions
- Androgenic Alopecia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mohammed Abd El Mawgoud AmerUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sildenafil 2% | Experimental | Drug: Sildenafil 2%will receive topical sildenafil 2% twice daily for 6 months. |
| Minoxidil 5 % | Experimental | Drug: Minoxidil 5 %will receive topical minoxidil 5 % twice daily for 6 months |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects clinically and dermoscopic diagnosed with AGA.
- Age ranges from 18 to 45 years old.
- Males
- Willingness to provide pictures and follow-up studies.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sildenafil 2%Also: Local Scalp InjectionPatients with male androgenic alopecia will be given topical Sildenafil 2% to apply twice daily for 6 consecutive months and then follow up. | Drug | Sildenafil 2% |
| Minoxidil 5 %Also: Local Scalp InjectionPatients with male androgenic alopecia will be given topical Minoxidil 5 % to apply twice daily for 6 consecutive months and then follow up. | Drug | Minoxidil 5 % |
Primary outcome
Improvement changes
Time frame: 6 months
improvement will be assessed by comparing the trichoscopic photos before and after treatment as regard hair density
2 secondary outcomes
Patient's satisfaction
Time frame: 6 months
Complications
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed Amer, MD principal investigator
Al-Azhar university Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sildenafil 2% and Minoxidil 5 % in people with Androgenic Alopecia, run by Mohammed Abd El Mawgoud Amer at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yassir Hagag, MBBCH (+201021121721, yassir_hagag@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement changes (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.