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T4N5 Liposome Lotion for Xeroderma Pigmentosum

Phase 3
Waitlist Available
Research Sponsored by Applied Genetics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 1.66 to 60
All actinic keratoses removed prior to treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing whether T4N5 liposome lotion can reduce actinic keratoses or other sun-induced skin damage in patients with xeroderma pigmentosum.

Who is the study for?
This trial is for people aged between approximately 2 and 60 with xeroderma pigmentosum, who have had at least one actinic keratosis removed. They should be in good health overall, not use illegal drugs, and women must not be pregnant or nursing. Women able to become pregnant must use effective contraception.Check my eligibility
What is being tested?
The study is testing T4N5 liposome lotion against a placebo to see if it can prevent skin lesions like actinic keratoses in patients with xeroderma pigmentosum. It's a phase III trial where participants are randomly assigned the real lotion or a fake one without knowing which they received.See study design
What are the potential side effects?
Potential side effects of T4N5 liposome lotion aren't detailed here but could include reactions at the application site such as redness, itching, or irritation given its topical nature.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 2 and 60 years old.
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I have had all precancerous skin spots removed.
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I have been diagnosed with xeroderma pigmentosum.
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I have been diagnosed with at least one actinic keratosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Find a Location

Who is running the clinical trial?

Applied GeneticsLead Sponsor
1 Previous Clinical Trials
180 Total Patients Enrolled
Daniel B. Yarosh, PhDStudy ChairApplied Genetics

Media Library

Placebo Lotion Clinical Trial Eligibility Overview. Trial Name: NCT00002811 — Phase 3
Precancerous Conditions Research Study Groups:
Precancerous Conditions Clinical Trial 2023: Placebo Lotion Highlights & Side Effects. Trial Name: NCT00002811 — Phase 3
Placebo Lotion 2023 Treatment Timeline for Medical Study. Trial Name: NCT00002811 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this therapy been green-lit by the FDA?

"This assessment gave the treatment a 3 out of 3 for safety because it is a Phase 3 trial. That designation means that, in addition to some data supporting efficacy, there are multiple rounds of data supporting safety."

Answered by AI

How do I qualify to take part in this experiment?

"This trial is looking for 30 participants who currently have precancerous conditions. The ideal candidate will be between the ages of 2 and 60, in good general health, with no illegal drug use or history of mental illness. Additionally, they must not be pregnant or nursing, and must be willing to undergo a negative pregnancy test if necessary. Fertile women must also agree to use effective contraception during the study period. Finally, patients must have a confirmed diagnosis of xeroderma pigmentosum, as well as at least one histologically confirmed actinic keratosis. All actinic keratoses must be removed prior to"

Answered by AI

In how many different places is this trial being conducted?

"There are a total of 7 study locations, which include State University of New york Health Sciences Center - Stony Brook in Long Island, University of Minnesota Medical School in the twin-cities area, and University of Texas - MD Anderson Cancer Center down south near Houston."

Answered by AI

Are people still being signed up for this clinical trial?

"This study, which was last updated over 6 years ago, is not currently looking for new patients. However, there are 60 other trials with open recruitment at this time."

Answered by AI

Could octogenarians potentially benefit from this research?

"This study's age requirements for enrollment start at 2 years old and end at 60."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~1 spots leftby Apr 2025