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Cryosurgery and Cream Combination for Actinic Keratosis

Primary Purpose

Actinic Keratosis

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Carac Cream

Placebo Cetaphil cream

About this trial

This is an interventional treatment trial for Actinic Keratosis focused on measuring Wake Forest, Actinic Keratosis, Cryosurgery, Cream

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Must be male or female and at least 18 years of age. Each subject must demonstrate good health as determined by a baseline medical history.
Female subjects myst be of either non-childbearing potential, or childbearing potential provided: negative urine pregnancy test and using two acceptable methods of effective contraception (abstinence, birth control pills.patch, DepoProvera, tubal ligation, vasectomy of the partner in a monogamous relationship, condoms and spermicidal form or gel and/or cervical cap or sponge), as determined by the investigator
At least eight clinically typical, visible and discrete AK lesions within the treatment area on the face or balding scalp
Subjects must be able and willing to comply with study procedures and have provided written informed consent.

Exclusion Criteria:

Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within the selected treatment area in the previous four weeks.
Treatment with systemic medications that suppress the immune system within the previous four weeks.
Field treatments with topical 5-FU, imiquimod, diclofenac, or photodynamic therapy, or more widespread field treatment with dermabrasion, medium or greater depth chemical peel, or laser resurfacing within the previous six months.
Any known dihydropyrimidine dehydrogenase enzyme deficiency.
In addition, subjects who have any skin condition or disease that may require concurrent therapy or may confound the evaluation as determined by the investigator, or a history of hypersensitivity to any of the formulation components will be excluded from study.
Subjects may not use other topical agents such as glycolic acid products, alpha-hydroxy acid products, retinoids and chemical peel agents on teh treatment area while on study. The use of these products are not allowed four weeks prior to study enrollment. Introduction of any other prescription medication, topical or systemic for actinic keratosis while participating in the study is not permitted.
Pregnant women, women who are breast feeding, or women of childbearing potential who are not practicing two acceptable methods of effective contraception.

Sites / Locations

Wake Forest University Health Sciences Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1 Carac (fluorouracil) 0.5% cream

Group 2 Placebo

Arm Description

Carac cream (fluorouracil) 0.5% applied daily on the face for one week

Placebo Cetaphil cream applied daily on the face for one week

Outcomes

Primary Outcome Measures

Number Participants With 100% Clearance

The primary endpoint is number of participants that receive 100% clearance of AK lesions from treatment initiation to end of treatment

Secondary Outcome Measures

Number of Participants With 75% Clearance

The secondary endpoint is number of participants that receive 75 % clearance of

Full Information

NCT ID

NCT03037541

First Posted

September 8, 2011

Last Updated

July 30, 2018

Sponsor

Wake Forest University Health Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03037541

Brief Title

Cryosurgery and Cream Combination for Actinic Keratosis

Official Title

A Single-Center, Randomized, Single-Blinded, Placebo-Controlled Trial on the Efficacy of Cryosurgery and 5-Fluorouracil 0.5% Cream Combination Therapy for the Treatment of Actinic Keratosis

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

January 5, 2011 (Actual)

Primary Completion Date

October 29, 2013 (Actual)

Study Completion Date

October 29, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Carac 0.5% cream is approved for daily topical treatment of AK's for up to four weeks as tolerated, though local irritation often occurs within the first week of treatment and increases in a dose-dependent manner. In this study, the investigators will examine the combination of standard cryosurgery treatment followed by a shortened course of topical fluorouracil cram. The investigators anticipate that a one week treatment course will maintain overall effectiveness when combined with previous cryosurgery, but will reduce the overall adverse effects of topical therapy due to the reduced treatment time and the presence of fewer baseline lesions to treat. This treatment approach may provide a more acceptable risk/benefit ratio option for patients with more extensive disease and simplify standard combination treatment options. The primary objective is to evaluate the efficacy of combination cryosurgery and 5-fluorouracil0.5% cream, compared to combination cryosurgery and placebo in the treatment of actinic keratosis lesions. The efficacy of this combination therapy will be evaluated by assessing AK lesion clearance. The primary efficacy parameter will be 10% clearance of all AK lesions from treatment initiation to end-of-treatment.

Detailed Description

This is a randomized (1:1), single-blind, placebo controlled, single center prospective study. Subjects will first undergo cryosurgery of all clinically apparent AK lesions, limited to the face or balding scalp. Three weeks after cryosurgery, subjects will then be randomized (1:1 according to standard randomization tables) and directed to apply either Carac 0.5% cream or placebo cream (Cetaphil Cream) to the face or balding scalp at bedtime for seven consecutive days, washed off each following morning. Each does of study cream will be applied at approximately the same time of day and will remain on the skin for approximately eight hours. Subject evaluation, Investigator Global Assessments, Quality of Life lesion counts and photography shall be performed at Baseline. At Week 3, study drug will be dispensed and the global assessments and assessment of improvement will be performed. A Medication Tolerability Assessment will occur at Week 4 when the study drug will be returned. Investigator Global Assessment, lesion count, Global Assessment of Improvement and Quality of Life will be measured at Week 8 and Week 26 (or end of study). Photography will be done at Week 26 or end of study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Actinic Keratosis

Keywords

Wake Forest, Actinic Keratosis, Cryosurgery, Cream

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1 Carac (fluorouracil) 0.5% cream

Arm Type

Experimental

Arm Description

Carac cream (fluorouracil) 0.5% applied daily on the face for one week

Arm Title

Group 2 Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo Cetaphil cream applied daily on the face for one week

Intervention Type

Drug

Intervention Name(s)

Carac Cream

Intervention Description

Carac Cream will be used once daily for seven consecutive days

Intervention Type

Drug

Intervention Name(s)

Placebo Cetaphil cream

Other Intervention Name(s)

Cetaphil

Intervention Description

Placebo Cetaphil Cream will be used once daily for seven consecutive days

Primary Outcome Measure Information:

Title

Number Participants With 100% Clearance

Description

The primary endpoint is number of participants that receive 100% clearance of AK lesions from treatment initiation to end of treatment

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Number of Participants With 75% Clearance

Description

The secondary endpoint is number of participants that receive 75 % clearance of

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Must be male or female and at least 18 years of age. Each subject must demonstrate good health as determined by a baseline medical history. Female subjects myst be of either non-childbearing potential, or childbearing potential provided: negative urine pregnancy test and using two acceptable methods of effective contraception (abstinence, birth control pills.patch, DepoProvera, tubal ligation, vasectomy of the partner in a monogamous relationship, condoms and spermicidal form or gel and/or cervical cap or sponge), as determined by the investigator At least eight clinically typical, visible and discrete AK lesions within the treatment area on the face or balding scalp Subjects must be able and willing to comply with study procedures and have provided written informed consent. Exclusion Criteria: Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within the selected treatment area in the previous four weeks. Treatment with systemic medications that suppress the immune system within the previous four weeks. Field treatments with topical 5-FU, imiquimod, diclofenac, or photodynamic therapy, or more widespread field treatment with dermabrasion, medium or greater depth chemical peel, or laser resurfacing within the previous six months. Any known dihydropyrimidine dehydrogenase enzyme deficiency. In addition, subjects who have any skin condition or disease that may require concurrent therapy or may confound the evaluation as determined by the investigator, or a history of hypersensitivity to any of the formulation components will be excluded from study. Subjects may not use other topical agents such as glycolic acid products, alpha-hydroxy acid products, retinoids and chemical peel agents on teh treatment area while on study. The use of these products are not allowed four weeks prior to study enrollment. Introduction of any other prescription medication, topical or systemic for actinic keratosis while participating in the study is not permitted. Pregnant women, women who are breast feeding, or women of childbearing potential who are not practicing two acceptable methods of effective contraception.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph Jorizzo, MD

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wake Forest University Health Sciences Department of Dermatology

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Cryosurgery and Cream Combination for Actinic Keratosis

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