Clinical Trials Directory

Trials / Unknown

UnknownNCT00002811

T4N5 Liposome Lotion Compared With Placebo Lotion for Preventing Actinic Keratoses in Patients With Xeroderma Pigmentosum

A RANDOMIZED, DOUBLE BLIND, MULTI-CENTER CLINICAL STUDY TO TEST THE SAFETY AND EFFICACY OF T4N5 LIPOSOME LOTION ON PATIENTS WITH XERODERMA PIGMENTOSUM IN THE PROTECTION AGAINST ACTINIC KERATOSES

Status
Unknown
Phase
Phase 3
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Applied Genetics · Industry
Sex
All
Age
2 Years – 60 Years
Healthy volunteers
Not accepted

Summary

RATIONALE: Patients with xeroderma pigmentosum are more likely to develop skin lesions in sun-affected areas. These skin lesions, such as actinic keratoses, can develop into skin cancer. T4N5 liposome lotion may reduce actinic keratoses or other sun-induced skin damage in patients with xeroderma pigmentosum. PURPOSE: Randomized double-blinded phase III trial to compare treatment using T4N5 liposome lotion with treatment using placebo in reducing actinic keratoses and other sun-induced skin damage in patients with xeroderma pigmentosum.

Detailed description

OBJECTIVES: I. Compare the safety and efficacy of T4N5 liposome lotion vs. a placebo lotion in reducing the incidence of actinic keratoses and protecting against other ultraviolet skin damage in patients with xeroderma pigmentosum. OUTLINE: Randomized, double-blind study. Groups of 6 patients are randomly assigned in a 2:1 ratio to Arms I and II, respectively. Arm I: Chemoprevention. Lotion composed of T4 endonuclease V protein encapsulated in liposomes and suspended in phosphate-buffered saline in a hydrogel base, T4N5 Liposome Lotion, T4N5. Arm II: Control. Liposomes suspended in phosphate-buffered saline in a hydrogel base, Placebo, PLCB. PROJECTED ACCRUAL: 6-30 patients will be entered in this multicenter study.

Conditions

Interventions

TypeNameDescription
DRUGliposomal T4N5 lotion

Timeline

Start date
1996-07-01
First posted
2004-09-02
Last updated
2013-11-06

Locations

9 sites across 3 countries: United States, Germany, United Kingdom

Source: ClinicalTrials.gov record NCT00002811. Inclusion in this directory is not an endorsement.