Effect of Minoxidil Solution Iontophoresis on Androgenic Alopecia

NCT ID: NCT07056933

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-08
• Study Completion Date: 2025-11-30

Brief Summary

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.

Conditions

Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Minoxidil-treated scalp

5% minoxidil through iontophoresis will be applied to one half of the scalp twice daily at home.

Group Type: EXPERIMENTAL

Minoxidil solution iontophoresis

Intervention Type: OTHER

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-treated scalp

The other half of the scalp will receive a placebo solution, (eg saline) with current application.

Group Type: ACTIVE_COMPARATOR

saline solution iontophoresis

Intervention Type: OTHER

The other half of the scalp of the participants will be treated with placebo saline solution ( control) with the current application.

Interventions

Minoxidil solution iontophoresis

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.

Intervention Type: OTHER

saline solution iontophoresis

The other half of the scalp of the participants will be treated with placebo saline solution ( control) with the current application.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Medically unstable and uncooperative patients.
• Immunocompromised status.
• History of skin cancer.
• Recurrent herpes viral infection.
• Pregnancy or breastfeeding status.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Ibrahim Mohammed Ahmed

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heba Abdelgayed

Role: STUDY_DIRECTOR

Cairo University

Amal Abd Elbaky, Professor

Role: STUDY_CHAIR

Cairo University

Locations

Mahmoud Ibrahim Mohamed

Zagazig, , Egypt

Countries

Egypt

Central Contacts

Mahmoud Ahmed, Master

Role: CONTACT

drmahmoudmanie@gmail.com

0121223877

Doaa Aly, PHD

Role: CONTACT

Doaa.atef@cu.edu.eg

0112466339

Other Identifiers

012/005693

Identifier Type: -

Identifier Source: org_study_id