Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002811
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
1999-11-01
Brief Title:
T4N5 Liposome Lotion Compared With Placebo Lotion for Preventing Actinic Keratoses in Patients With Xeroderma Pigmentosum
Sponsor:
Applied Genetics
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
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
Status Verified Date:
2007-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 21 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
OUTLINE Randomized double-blind study Groups of 6 patients are randomly assigned in a 21 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V96-0953 | None | None | None |
| AGI-007 | None | None | None |
| AGI-FDR000992 | None | None | None |