CLINICAL TRIAL
Treatment for Ito Syndrome
Recruiting · 18 - 65 · All Sexes · Dallas, TX
Intense Pulsed Light Therapy Combined With a Fractionated 1927nm Laser for Diffuse Pigmentation and Actinic Changes.
See full descriptionAbout the trial for Ito Syndrome
Eligible Conditions
Pigmentation Disorders · Skin Pigment
Treatment Groups
This trial involves a single treatment. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.
Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Eligibility
This trial is for patients born any sex between 18 and 65 years old. There are 10 eligibility criteria to participate in this trial as listed below.
Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:View All
Healthy male and female adults between 20-60 years of age.
You have a skin type of I-IV. show original
Individuals deemed by the Investigator to have a significant amount of pigmentation/melasma and that desire correction of this condition.
Individuals willing to withhold aesthetic therapies, or other therapies judged to potentially impact results to the treatment areas for the duration of the study.
Barrier methods with spermicide: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
Intrauterine device (IUD) or intrauterine system (IUS)
Surgical sterilization (e.g. vasectomy confirmed to be effective by sperm count check, tubal occlusion, hysterectomy, bilateral salpingectomy/oophorectomy)
Abstinence from heterosexual intercourse, when this is in line with the preferred and usual lifestyle of the subject show original
You have used hormonal contraception for at least 6 months. show original
You are a woman of childbearing potential who agrees to take a urine pregnancy test at the Screening visit or when deemed by Investigator show original
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Approximate Timelines
Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Through study completion, an average of 10 months
Screening: ~3 weeks
Treatment: Varies
Reporting: Through study completion, an average of 10 months
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like
Measurement Requirements
This trial is evaluating whether Treatment will improve 1 primary outcome and 4 secondary outcomes in patients with Ito Syndrome. Measurement will happen over the course of Baseline and 3 Months.
Change from Baseline of red areas at 3 Months
BASELINE AND 3 MONTHSBASELINE AND 3 MONTHS
Numeric analysis of red areas will be analyzed using Vectra H2 3D analysis.
Standard, close up and cross-polarized photography will be utilized for evaluation of pigmentation.Change from Baseline of Vasculature Density
THROUGH STUDY COMPLETION, AN AVERAGE OF 10 MONTHSTHROUGH STUDY COMPLETION, AN AVERAGE OF 10 MONTHS
Optical Coherence Topographic (OCT)/histological images will be obtained to evaluate vasculature density.Adverse Events
THROUGH STUDY COMPLETION, AN AVERAGE OF 10 MONTHSTHROUGH STUDY COMPLETION, AN AVERAGE OF 10 MONTHS
The study team will monitor incidence, severity, and relatedness of adverse events throughout the study.Change from Baseline of Skin Tissue Density
THROUGH STUDY COMPLETION, AN AVERAGE OF 10 MONTHSTHROUGH STUDY COMPLETION, AN AVERAGE OF 10 MONTHS
Optical Coherence Topographic (OCT)/histological images will be obtained to evaluate skin tissue density.Change from Baseline of Skin Thickness
THROUGH STUDY COMPLETION, AN AVERAGE OF 10 MONTHSTHROUGH STUDY COMPLETION, AN AVERAGE OF 10 MONTHS
Optical Coherence Topographic (OCT)/histological images will be obtained to evaluate skin thickness.Who is running the study
Principal InvestigatorA. C.
Prof. Abby Culver, Assistant Professor
University of Texas Southwestern Medical Center
Patient Q & A Section
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Other questions from users
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any geographic restrictions to consider when applying for this trial?
Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.
Will my insurance cover participating in this trial?
In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.
See if you qualify for this trial
Get access to this novel treatment for Ito Syndrome by sharing your contact details with the study coordinator.