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mTOR inhibitor
Topical Rapamycin for Vitiligo
Phase 2
Waitlist Available
Led By Ahmad Aleisa, MD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients 13 years of age and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is testing whether a drug called rapamycin can treat vitiligo. People will apply it to one side of their body and a placebo to the other to see if there's a difference. The study will also see if patients are happy with the treatment and if there are any side effects.
Who is the study for?
This trial is for people aged 13 and older with nonsegmental vitiligo, which causes loss of skin color in blotches. It's not for those on certain medications affecting the immune system, have had transplants, serious infections, are pregnant or currently treating vitiligo.Check my eligibility
What is being tested?
The study tests if daily use of a cream called rapamycin can help with vitiligo. Participants will apply two strengths of rapamycin to different body lesions and a placebo to another lesion for six months to compare effectiveness and satisfaction.See study design
What are the potential side effects?
Possible side effects may include local skin reactions like redness or irritation where the cream is applied. Since rapamycin affects the immune system, there might be an increased risk of infection or other less common systemic effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 13 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of lesions with no response
Number of lesions with partial response
Numbers of lesions with complete response
Secondary outcome measures
Average score of Dermatology Quality of Life questionnaire (or Teenager Quality of Life Index)
Side effects data
From 2009 Phase 4 trial • 20 Patients • NCT0022367831%
pneumonia
15%
acute kidney failure
8%
dehydration
8%
hip replacement
8%
acute rejection
8%
total abdominal hysterectomy and salpingectomy
8%
anemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rapamycin Group
CNI Group
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Topical rapamycin 0.001%Experimental Treatment1 Intervention
Patients randomized to this arm of the study will apply 2 finger tip units (FTU) or 0.5 cc topical rapamycin 0.001% cream daily for 6 months
Group II: Topical rapamycin 0.1%Active Control1 Intervention
Patients randomized to this arm of the study will apply 2 FTU (0.5 cc) topical rapamycin 0.1% cream daily for 6 months
Group III: PlaceboPlacebo Group1 Intervention
All patients will apply 2 FTU (0.5 cc) topical placebo cream daily for 6 months to the corresponding anatomic location on the opposite side of the body where the experimental drug is not being applied
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sirolimus
FDA approved
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
932 Previous Clinical Trials
7,394,240 Total Patients Enrolled
1 Trials studying Vitiligo
4 Patients Enrolled for Vitiligo
American Skin AssociationOTHER
2 Previous Clinical Trials
42 Total Patients Enrolled
1 Trials studying Vitiligo
12 Patients Enrolled for Vitiligo
Ahmad Aleisa, MDPrincipal InvestigatorMedical University of South Carolina
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of weak immune system from birth.I have had a serious or life-threatening infection in the past.You have vitiligo on specific areas of your skin or on your mucous membranes.I am currently taking medication that strongly affects liver enzymes.You have intentionally weakened your immune system in the past.You have had an organ transplant in the past.I am currently being treated for vitiligo.I am currently taking medication that affects liver enzyme levels.I am 13 years old or older.You have nonsegmental vitiligo.I cannot take rapamycin due to health reasons.
Research Study Groups:
This trial has the following groups:- Group 1: Topical rapamycin 0.001%
- Group 2: Placebo
- Group 3: Topical rapamycin 0.1%
Awards:
This trial has 2 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Vitiligo Patient Testimony for trial: Trial Name: NCT05342519 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies for research participants in this trial?
"Per information sourced from clinicaltrials.gov, this particular medical research is actively recruiting participants since it was initially posted on July 28th 2022 and last amended two days later."
Answered by AI
To what extent can Rapamycin endanger a patient's wellbeing?
"Considering the status of this Phase 2 trial, our team at Power has assigned Rapamycin a safety rating of 2. This reflects that there is some evidence for its security but none yet concerning its efficacy."
Answered by AI
What is the current patient sample size of this research trial?
"Affirmative. Clinicaltrials.gov attests that this research endeavour, which was initially published on July 28th 2022, is in the process of recruiting individuals. This trial has a goal to enrol 20 participants from 1 medical centre."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
Nevada
Texas
Other
How old are they?
< 18
18 - 65
What site did they apply to?
Medical University of South Carolina
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
2
3+
What questions have other patients asked about this trial?
Must I travel to SC?
PatientReceived no prior treatments
Why did patients apply to this trial?
never tried anything for vitiligo. I am aplying it because my 12 year old son has segmental Vitiligo and it is spreading so fast and no medicine or UV therapy is working.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
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