Effect of Minoxidil Solution Iontophoresis on Androgenic Alopecia

Обзор

The aim of the study is to evaluate the therapeutic efficiency of minoxidil solution iontophoresis on Androgenic Alopecia.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Change in the number of hair follicles [Срок оценки: 12 weeks]

Вторичные конечные точки (1)

• Change of hair thickness [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Mahmoud Ibrahim Mohamed — Zagazig

Идентификаторы

NCT: NCT07056933 · 012/005693

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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