NCT07056933

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

July 8, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

July 9, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

June 30, 2025

Last Update Submit

June 30, 2025

Conditions

Alopecia

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Secondary Outcomes (1)

  • Change of hair thickness

    12 weeks

Study Arms (2)

Minoxidil-treated scalp

EXPERIMENTAL

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

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.

Other: saline solution iontophoresis

Interventions

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.

Minoxidil-treated scalp
saline solution iontophoresisOTHER

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

Saline-treated scalp

Eligibility Criteria

Age18 Years - 65 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahmoud Ibrahim Mohamed

Zagazig, Egypt

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Heba Abdelgayed

    Cairo University

    STUDY DIRECTOR

  • Amal Abd Elbaky, Professor

    Cairo University

    STUDY CHAIR

Central Study Contacts

Mahmoud Ahmed, Master

CONTACT

0121223877drmahmoudmanie@gmail.com

Doaa Aly, PHD

CONTACT

0112466339Doaa.atef@cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 30, 2025

First Posted

July 9, 2025

Study Start

July 8, 2025

Primary Completion

November 15, 2025

Study Completion

November 30, 2025

Last Updated

July 9, 2025

Record last verified: 2025-06

Locations

EG(1)