Cryosurgery and Cream Combination for Actinic Keratosis

NCT03037541 | Completed Phase 3 Results FDA Drug

• 1 other identifier: IRB00014209
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Actinic Keratosis

Keywords

Wake Forest; Actinic Keratosis; Cryosurgery; Cream

Outcome Measures

Primary Outcomes (1)

• 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

  24 weeks

Secondary Outcomes (1)

• Number of Participants With 75% Clearance

  24 weeks

Study Arms (2)

Group 1 Carac (fluorouracil) 0.5% cream

EXPERIMENTAL

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

Drug: Carac Cream

Group 2 Placebo

PLACEBO COMPARATOR

Placebo Cetaphil cream applied daily on the face for one week

Drug: Placebo Cetaphil cream

Interventions

Carac Cream DRUG

Carac Cream will be used once daily for seven consecutive days

Group 1 Carac (fluorouracil) 0.5% cream

Placebo Cetaphil cream DRUG

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

Also known as: Cetaphil

Group 2 Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences Department of Dermatology

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

cetyl alcohol, propylene glycol, sodium lauryl sulfate non-lipid cleansing lotion

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Joseph Jorizzo, MD
• Organization: Wake Forest University Health Sciences

jjorizzo@wakehealth.edu

336-716-3775

Study Officials

• Joseph Jorizzo, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2011
• First Posted: January 31, 2017
• Study Start: January 5, 2011
• Primary Completion: October 29, 2013
• Study Completion: October 29, 2013
• Last Updated: August 29, 2018
• Results First Posted: March 23, 2017

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)