AlopeciaNCT07056933
Effect of Minoxidil Solution Iontophoresis on Androgenic Alopecia
A study testing Minoxidil solution iontophoresis and saline solution iontophoresis in people with Alopecia, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the study is to evaluate the therapeutic efficiency of minoxidil solution iontophoresis on Androgenic Alopecia. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Alopecia
- What is being tested?
- Minoxidil solution iontophoresis and saline solution iontophoresis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Jul 2025to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Twenty-five adult aged 18-65 with diagnosed androgenic alopecia.
- They diagnosed as Androgenic alopeacia by their physicians and referred for physical therapy management.
- Medically and psychologically stable patients.
Who cannot join
- History of hypersensitivity to minoxidil solution or Intophoresis.
- Scalp infection
- Concurrent hair loss treatments.
- Patients who suffer from hypertrophic and/or keloidal scars and a skin condition in the area of Androgenic alopecia that would interfere with study procedures.
- plaque psoriasis, tattoo, birthmark, facial hair.
- Patients with medical red flags as severe psychiatric disorder or cognitive deficits.
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- Medically unstable and uncooperative patients.
- Immunocompromised status.
- History of skin cancer.
- Recurrent herpes viral infection.
- Pregnancy or breastfeeding status.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The aim of the study is to evaluate the therapeutic efficiency of minoxidil solution iontophoresis on Androgenic Alopecia.
Read the detailed description
Hair is an important component of identity and self-image. Hair loss can lead to a variety of psychological difficulties and have a negative impact on quality of life (QoL). Loss of self-confidence lowered self-esteem, and heightened self-consciousness are common responses to hair loss, particularly for women. People with alopecia are more likely to develop depression and anxiety.
Some studies have proposed iontophoresis and ultrasound as energetic drug delivery methods to favor topical therapy of alopecia. Iontophoresis is a non-invasive technique that applies a small electric current (of no more than 0.5 mA/cm2) on the skin's surface to increase and control drug delivery. The technique is widely studied to stimulate the skin penetration and permeation of hydrophilic drugs, which would not be absorbed by the skin when passively applied. The transport of drugs through the skin as a result of the electric current is driven by two different mechanisms, ie, electromigration in the case of charged drugs and electroosmosis in the case of neutral drugs.
Furthermore the need of this study is developed from the lack in quantitative knowledge and information in published studies which investigate effect of minoxidil solution iontophoresis on Androgenic alopecia.
- Conditions
- Alopecia
- Being tested
- Minoxidil solution iontophoresis, saline solution iontophoresis
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minoxidil solution iontophoresisOther
The half of the scalp of the participants will be treated with 5% minoxidil solution through Iontophoresis that will be applied at small low voltage (typically 10 V or less) continuous constant current (typically 0.5 mA/cm2 or less) to push a charged drug into skin or other tissue, twice daily at home.
saline solution iontophoresisOther
The other half of the scalp of the participants will be treated with placebo saline solution ( control) with the current application.
| Study group | Role | What they receive |
|---|---|---|
| Minoxidil-treated scalp | Experimental | 5% minoxidil through iontophoresis will be applied to one half of the scalp twice daily at home. Receives: Other: Minoxidil solution iontophoresis |
| Saline-treated scalp | Active comparator | The other half of the scalp will receive a placebo solution, (eg saline) with current application. Receives: Other: saline solution iontophoresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of hair follicles
Trichoscopy will be used to detect the change in the number of hair follicles as a comparison between before and after intervention. Trichoscopy helped with the definitive diagnosis of Alopeacia in patients for whom the clinical diagnosis was doubtful, which was confirmed by histopathology. Thus trichoscopy is a noninvasive, sensitive and specific investigation that is valuable in women with alopecia, the cause of which is otherwise very difficult to assess clinically, and it has a definite role in the diagnosis of cases with an atypical clinical picture.Trichoscopy results were obtained in frontal, occipital and both temporal areas of scalp, including number of yellow dots and vellus hairs, number of hairs in one pilosebaceous unit and percentage of follicular ostia with perifollicular hyperpigmentation.
Measured: 12 weeks
Secondary outcomes (1)
Change of hair thickness
Global Photographic System will be used to detect the change of hair thickness as a comparison between before and after intervention.
The Global Photographic Assessment is useful for determining overall clinical changes in a patient over times period in a standardized manner, Global Photographs are head shots taken a short distance away from the patients, a patient is usually photographed from the front, top, sides, and back to show accordingly a frontal hair line, crown, partition and vertex.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start8 Jul 2025 (estimated)
- Primary completion15 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlopeciaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ibrahim Mohammed Ahmed, Cairo University
- Investigators
- Heba Abdelgayed, Study director, Cairo UniversityAmal Abd Elbaky, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056933
- Sponsor's protocol ID
- 012/005693
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Minoxidil Solution Iontophoresis on Androgenic Alopecia
- ClinicalTrials.gov ID
- NCT07056933
- Acronym / sponsor ID
- 012/005693
- Conditions
- Alopecia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 8 Jul 2025 (estimated)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 9 Jul 2025 (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.
The aim of the study is to evaluate the therapeutic efficiency of minoxidil solution iontophoresis on Androgenic Alopecia.
Detailed description
Hair is an important component of identity and self-image. Hair loss can lead to a variety of psychological difficulties and have a negative impact on quality of life (QoL). Loss of self-confidence lowered self-esteem, and heightened self-consciousness are common responses to hair loss, particularly for women. People with alopecia are more likely to develop depression and anxiety.
Some studies have proposed iontophoresis and ultrasound as energetic drug delivery methods to favor topical therapy of alopecia. Iontophoresis is a non-invasive technique that applies a small electric current (of no more than 0.5 mA/cm2) on the skin's surface to increase and control drug delivery. The technique is widely studied to stimulate the skin penetration and permeation of hydrophilic drugs, which would not be absorbed by the skin when passively applied. The transport of drugs through the skin as a result of the electric current is driven by two different mechanisms, ie, electromigration in the case of charged drugs and electroosmosis in the case of neutral drugs.
Furthermore the need of this study is developed from the lack in quantitative knowledge and information in published studies which investigate effect of minoxidil solution iontophoresis on Androgenic alopecia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minoxidil-treated scalp | Experimental | Other: Minoxidil solution iontophoresis5% minoxidil through iontophoresis will be applied to one half of the scalp twice daily at home. |
| Saline-treated scalp | Active comparator | Other: saline solution iontophoresisThe other half of the scalp will receive a placebo solution, (eg saline) with current application. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Twenty-five adult aged 18-65 with diagnosed androgenic alopecia.
- They diagnosed as Androgenic alopeacia by their physicians and referred for physical therapy management.
- Medically and psychologically stable patients.
Key exclusion criteria (11 listed)
- History of hypersensitivity to minoxidil solution or Intophoresis.
- Scalp infection
- Concurrent hair loss treatments.
- Patients who suffer from hypertrophic and/or keloidal scars and a skin condition in the area of Androgenic alopecia that would interfere with study procedures.
- plaque psoriasis, tattoo, birthmark, facial hair.
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 |
|---|---|---|
| Minoxidil solution iontophoresisThe half of the scalp of the participants will be treated with 5% minoxidil solution through Iontophoresis that will be applied at small low voltage (typically 10 V or less) continuous constant current (typically 0.5 mA/cm2 or less) to push a charged drug into skin or other tissue, twice daily at home. | Other | Minoxidil-treated scalp |
| saline solution iontophoresisThe other half of the scalp of the participants will be treated with placebo saline solution ( control) with the current application. | Other | Saline-treated scalp |
Primary outcome
Change in the number of hair follicles
Time frame: 12 weeks
Trichoscopy will be used to detect the change in the number of hair follicles as a comparison between before and after intervention. Trichoscopy helped with the definitive diagnosis of Alopeacia in patients for whom the clinical diagnosis was doubtful, which was confirmed by histopathology. Thus trichoscopy is a noninvasive, sensitive and specific investigation that is valuable in women with alopecia, the cause of which is otherwise very difficult to assess clinically, and it has a definite role in the diagnosis of cases with an atypical clinical picture.Trichoscopy results were obtained in frontal, occipital and both temporal areas of scalp, including number of yellow dots and vellus hairs, number of hairs in one pilosebaceous unit and percentage of follicular ostia with perifollicular hyperpigmentation.
1 secondary outcome
Change of hair thickness
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
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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.
Heba Abdelgayed study director
Cairo University
Amal Abd Elbaky, Professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minoxidil solution iontophoresis and saline solution iontophoresis in people with Alopecia, run by Cairo University 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 3 inclusion and 11 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: opening soon, as of the sponsor's last update on 9 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Ahmed, Master (0121223877, drmahmoudmanie@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of hair follicles (time frame: 12 weeks). 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 9 Jul 2025.