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CSP #562 - The VA Keratinocyte Carcinoma Chemoprevention Trial (VAKCCT)

Primary Purpose

Carcinoma, Basal Cell, Carcinoma, Squamous Cell, Skin Neoplasms

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

5-fluorouracil

Placebo, vehicle control

About this trial

This is an interventional prevention trial for Carcinoma, Basal Cell focused on measuring NMSC, nonmelanoma skin cancer, topical 5-FU 5% cream, Neoplasms, Antineoplastic Agents, Therapeutic Uses, Dermatologic Agents, Neoplasms by Site, carcinoma, basal cell, carcinoma, squamous cell

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Veteran who is at high risk for developing skin cancer defined as 2 keratinocyte carcinomas in the past 5 years, at least one of which was located on the face or ears

Exclusion Criteria:

Participants who are unable to speak English
Participants with KC at randomization
Participants currently using or having used field therapy for AKs on the face or ears in the past 3 years. The vast majority of these field treatments would have been with 5-FU cream. The investigators will allow recent use of therapies that are applied to individual AK lesions (e.g. cryotherapy), but not those that were used on an entire area (field) in the study treatment area Participants currently using or having used systemic 5-fluorouracil or oral capecitabine (Xeloda) within the past 3 years Participants with known allergy to sunscreen, triamcinolone and/or 5-fluorouracil.

Exclusions 6-l0: The investigators will exclude the small proportion who get their KCs for special reasons other than ultraviolet radiation exposure (see list below), since that etiologic difference, which is associated with a prognostic difference, could be associated with a biologic difference in response to chemoprevention efforts. These will include:

Solid organ transplant recipients, such as renal, hepatic, or cardiac transplant patients
Individuals with genetic disorders associated with very high cancer risk such as:
basal cell nevus syndrome
erythrodysplasia verruciformis
xeroderma pigmentosum
Arsenic exposure
PUVA (Psoralen plus UVA) treatment
Cutaneous T-cell lymphoma
Prior or current radiation therapy to the face and/or ears.

Additional exclusions (12-15) are:

Those who, in the opinion of the recruiting investigator, have very high mortality risk at randomization (less than 50% chance of surviving 4 years) due to co morbid illness such as metastatic cancer or COPD.
For women of childbearing potential an initial pregnancy test and ongoing birth control will be required for participation.
Patients with known dihydropyrimidine dehydrogenase (DPD) enzyme deficiency by self report or noted in the medical record (they have increased toxicity from systemic 5-FU, although screening for this is not part of dermatologic practice and will not be part of this study).
Patients on methotrexate (these will constitute about 1% of potentially eligible individuals) because they may have more severe reactions to topical 5-FU.

Sites / Locations

VA Palo Alto Health Care System, Palo Alto, CA
VA San Diego Healthcare System, San Diego, CA
VA Eastern Colorado Health Care System, Denver, CO
Bay Pines VA Healthcare System, Pay Pines, FL
Miami VA Healthcare System, Miami, FL
Atlanta VA Medical and Rehab Center, Decatur, GA
Edward Hines Jr. VA Hospital, Hines, IL
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Minneapolis VA Health Care System, Minneapolis, MN
Durham VA Medical Center, Durham, NC
Philadelphia VA Medical Center, Philadelphia, PA
Providence VA Medical Center, Providence, RI
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1: 5-fluorouracil

Arm 2: Placebo

Arm Description

Group assigned to blinded 5-FU (5-fluorouracil) cream applied to face and ears twice daily for maximum of 56 doses

Group assigned to blinded placebo, vehicle control cream applied to face and ears twice daily for maximum of 56 doses

Outcomes

Primary Outcome Measures

The Time to Diagnosis of the First Keratinocyte Carcinoma (KC) on the Face or Ears for Which Surgery is Performed

Diagnosis of the first Primary Basil Cell Carcinoma (BCC) or primary Squamous Cell Carcinoma (SCC) on the face or ears that was removed surgically.

Hazard Ratio for Surgically Treated KC

Secondary Outcome Measures

Full Information

NCT ID

NCT00847912

First Posted

February 18, 2009

Last Updated

May 18, 2021

Sponsor

VA Office of Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT00847912

Brief Title

CSP #562 - The VA Keratinocyte Carcinoma Chemoprevention Trial

Acronym

VAKCCT

Official Title

CSP #562 - The VA Keratinocyte Carcinoma Chemoprevention Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

June 26, 2009 (Actual)

Primary Completion Date

June 28, 2013 (Actual)

Study Completion Date

July 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The main purpose of this study is to see if 5-fluorouracil (5-FU) skin cream can prevent the growth of new skin cancers on the face and ears. The cost of trying to prevent skin cancer will be compared to the usual cost of treating skin cancer. Participants are being asked to be a part of this study because the participants have been treated for two or more skin cancers within the past five (5) years. At least one of these cancers occurred on the face or ears. Having had two or more skins cancers in the past 5 years makes it likely that participants will develop additional skin cancers in the future. Exposure to ultraviolet radiation from the sun or artificial sources such as tanning beds is a major cause of basal cell and squamous cell carcinoma of the skin. Using lotions, creams, or gels that contain sunscreens can help protect the skin from premature aging and damage that may lead to skin cancer. The 5-FU skin cream used in this study is FDA-approved to treat some types of skin cancers and spots that might become skin cancer. However, 5-FU skin cream has never been studied to see if it can prevent skin cancer. This drug is not approved by the FDA for how it will be used in this study. In this study, one half of the patients will use the 5-FU cream and the other half will use a skin cream that looks identical to the 5-FU cream but does not have 5-FU or any other active drug in it. Approximately twelve VA medical centers will work together in this study. About one thousand (1000) patients will be in this study. The study is sponsored by the U.S. Department of Veterans Affairs Cooperative Studies Program.

Detailed Description

Basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) of the skin, both of which are keratinocyte carcinomas (KCs), account for a half of all cancers in the United States, and over 100,000 diagnoses per year in the VA. The standard treatment for these KCs is excision of the lesion, and they cost the US health care system some $2.5 billion annually and about $100 million annually in the VA. There is no proven means to prevent KCs (except perhaps for a modest benefit of intensive daily sunscreen use). An effective prevention strategy would dramatically change the way high-risk patients are managed and could substantially reduce the costs of care. The investigators' preliminary analysis indicates that the savings will be $116 per high-risk patient and will account for a total national savings of over $11 million. These findings imply that the study would pay for itself by the end of 4 years. The investigators hypothesize that topical 5-fluorouracil (5-FU) chemoprevention will prevent skin cancer surgeries and will be cost-saving. To test this the investigators propose a randomized controlled trial of 5-FU compared to a vehicle control to the face and ears in a high-risk population. In the study, 1000 Veterans at high-risk of skin cancer defined as at least 2 KCs in the prior 5 years, at least one of which was on the face or ears, will be randomized to 5-FU or a vehicle control cream, and followed for 2 to 4 years. The primary endpoint will be surgery for any KC on the face and ears. The investigators will also assess the cost of care, quality of life, the side effects associated with treatment, and the prevalence and number of actinic keratoses, a skin cancer precursor and itself a cause of morbidity and cost. By targeting patients at high-risk, the study focuses on high-cost patients for whom this treatment could both improve outcomes (cancers and quality of life) and reduce costs.

6. Conditions and Keywords

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

Carcinoma, Basal Cell, Carcinoma, Squamous Cell, Skin Neoplasms, Skin Diseases, Neoplasms, Basal Cell, Neoplasms, Squamous Cell, Carcinoma

Keywords

NMSC, nonmelanoma skin cancer, topical 5-FU 5% cream, Neoplasms, Antineoplastic Agents, Therapeutic Uses, Dermatologic Agents, Neoplasms by Site, carcinoma, basal cell, carcinoma, squamous cell

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

954 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1: 5-fluorouracil

Arm Type

Experimental

Arm Description

Group assigned to blinded 5-FU (5-fluorouracil) cream applied to face and ears twice daily for maximum of 56 doses

Arm Title

Arm 2: Placebo

Arm Type

Placebo Comparator

Arm Description

Group assigned to blinded placebo, vehicle control cream applied to face and ears twice daily for maximum of 56 doses

Intervention Type

Drug

Intervention Name(s)

5-fluorouracil

Other Intervention Name(s)

Efudex, 5-FU

Intervention Description

Apply thin layer of topical 5-FU 5% cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily 5-FU, they will discontinue the treatment and initiate "cool-down" treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping 5-FU, if and only if the participant has not received at least the minimum 2 week (28 dose) course, 5-FU treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the "cool-down" routine will be followed, but 5-FU will be stopped.

Intervention Type

Drug

Intervention Name(s)

Placebo, vehicle control

Other Intervention Name(s)

Placebo

Intervention Description

Apply thin layer of vehicle control cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily vehicle control cream, they will discontinue the treatment and initiate "cool-down" treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping vehicle control cream, if and only if the participant has not received at least the minimum 2 week (28 dose) course, vehicle control cream treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the "cool-down" routine will be followed, but vehicle control cream will be stopped.

Primary Outcome Measure Information:

Title

The Time to Diagnosis of the First Keratinocyte Carcinoma (KC) on the Face or Ears for Which Surgery is Performed

Description

Diagnosis of the first Primary Basil Cell Carcinoma (BCC) or primary Squamous Cell Carcinoma (SCC) on the face or ears that was removed surgically.

Time Frame

From randomization to last visit prior to end of study date (6/30/2013), assessed up to four years

Title

Hazard Ratio for Surgically Treated KC

Time Frame

date of randomization to last visit before end of study follow up (6/30/2013), assessed up to four years

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Veteran who is at high risk for developing skin cancer defined as 2 keratinocyte carcinomas in the past 5 years, at least one of which was located on the face or ears Exclusion Criteria: Participants who are unable to speak English Participants with KC at randomization Participants currently using or having used field therapy for AKs on the face or ears in the past 3 years. The vast majority of these field treatments would have been with 5-FU cream. The investigators will allow recent use of therapies that are applied to individual AK lesions (e.g. cryotherapy), but not those that were used on an entire area (field) in the study treatment area Participants currently using or having used systemic 5-fluorouracil or oral capecitabine (Xeloda) within the past 3 years Participants with known allergy to sunscreen, triamcinolone and/or 5-fluorouracil. Exclusions 6-l0: The investigators will exclude the small proportion who get their KCs for special reasons other than ultraviolet radiation exposure (see list below), since that etiologic difference, which is associated with a prognostic difference, could be associated with a biologic difference in response to chemoprevention efforts. These will include: Solid organ transplant recipients, such as renal, hepatic, or cardiac transplant patients Individuals with genetic disorders associated with very high cancer risk such as: basal cell nevus syndrome erythrodysplasia verruciformis xeroderma pigmentosum Arsenic exposure PUVA (Psoralen plus UVA) treatment Cutaneous T-cell lymphoma Prior or current radiation therapy to the face and/or ears. Additional exclusions (12-15) are: Those who, in the opinion of the recruiting investigator, have very high mortality risk at randomization (less than 50% chance of surviving 4 years) due to co morbid illness such as metastatic cancer or COPD. For women of childbearing potential an initial pregnancy test and ongoing birth control will be required for participation. Patients with known dihydropyrimidine dehydrogenase (DPD) enzyme deficiency by self report or noted in the medical record (they have increased toxicity from systemic 5-FU, although screening for this is not part of dermatologic practice and will not be part of this study). Patients on methotrexate (these will constitute about 1% of potentially eligible individuals) because they may have more severe reactions to topical 5-FU.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin A. Weinstock, MD

Organizational Affiliation

Providence VA Medical Center, Providence, RI

Official's Role

Study Chair

Facility Information:

Facility Name

VA Palo Alto Health Care System, Palo Alto, CA

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304-1290

Country

United States

Facility Name

VA San Diego Healthcare System, San Diego, CA

City

San Diego

State/Province

California

ZIP/Postal Code

92161

Country

United States

Facility Name

VA Eastern Colorado Health Care System, Denver, CO

City

Denver

State/Province

Colorado

ZIP/Postal Code

80220

Country

United States

Facility Name

Bay Pines VA Healthcare System, Pay Pines, FL

City

Bay Pines

State/Province

Florida

ZIP/Postal Code

33744

Country

United States

Facility Name

Miami VA Healthcare System, Miami, FL

City

Miami

State/Province

Florida

ZIP/Postal Code

33125

Country

United States

Facility Name

Atlanta VA Medical and Rehab Center, Decatur, GA

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30033

Country

United States

Facility Name

Edward Hines Jr. VA Hospital, Hines, IL

City

Hines

State/Province

Illinois

ZIP/Postal Code

60141-5000

Country

United States

Facility Name

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02130

Country

United States

Facility Name

Minneapolis VA Health Care System, Minneapolis, MN

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55417

Country

United States

Facility Name

Durham VA Medical Center, Durham, NC

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

Facility Name

Philadelphia VA Medical Center, Philadelphia, PA

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Providence VA Medical Center, Providence, RI

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02908

Country

United States

Facility Name

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37212-2637

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24102420

Citation

Lee KC, Lew R, Weinstock MA. Improvement in precision of counting actinic keratoses. Br J Dermatol. 2014 Jan;170(1):188-91. doi: 10.1111/bjd.12629.

Results Reference

background

PubMed Identifier

25008439

Citation

Korgavkar K, Firoz EF, Xiong M, Lew R, Marcolivio K, Burnside N, Dyer R, Weinstock MA; VAKCC Trial Group. Measuring the severity of topical 5-fluorouracil toxicity. J Cutan Med Surg. 2014 Jul-Aug;18(4):229-35. doi: 10.2310/7750.2013.13143.

Results Reference

background

PubMed Identifier

25950503

Citation

Pomerantz H, Hogan D, Eilers D, Swetter SM, Chen SC, Jacob SE, Warshaw EM, Stricklin G, Dellavalle RP, Sidhu-Malik N, Konnikov N, Werth VP, Keri J, Lew R, Weinstock MA; Veterans Affairs Keratinocyte Carcinoma Chemoprevention (VAKCC) Trial Group. Long-term Efficacy of Topical Fluorouracil Cream, 5%, for Treating Actinic Keratosis: A Randomized Clinical Trial. JAMA Dermatol. 2015 Sep;151(9):952-60. doi: 10.1001/jamadermatol.2015.0502.

Results Reference

background

PubMed Identifier

24033340

Citation

Chen SC, Hill ND, Veledar E, Swetter SM, Weinstock MA. Reliability of quantification measures of actinic keratosis. Br J Dermatol. 2013 Dec;169(6):1219-22. doi: 10.1111/bjd.12591.

Results Reference

background

PubMed Identifier

27207349

Citation

Pomerantz H, Korgavkar K, Lee KC, Lew R, Weinstock MA; VAKCC Trial Group. Validation of Photograph-Based Toxicity Score for Topical 5-Fluorouracil Cream Application. J Cutan Med Surg. 2016 Sep;20(5):458-66. doi: 10.1177/1203475416643952. Epub 2016 Apr 18.

Results Reference

result

PubMed Identifier

28088997

Citation

Siegel JA, Luber AJ, Weinstock MA; Department of Veterans Affairs Topical Tretinoin Chemoprevention Trial and Department of Veterans Affairs Keratinocyte Carcinoma Chemoprevention Trial Groups. Predictors of actinic keratosis count in patients with multiple keratinocyte carcinomas: A cross-sectional study. J Am Acad Dermatol. 2017 Feb;76(2):346-349. doi: 10.1016/j.jaad.2016.09.020. No abstract available.

Results Reference

result

PubMed Identifier

28532759

Citation

Walker JL, Siegel JA, Sachar M, Pomerantz H, Chen SC, Swetter SM, Dellavalle RP, Stricklin GP, Qureshi AA, DiGiovanna JJ, Weinstock MA. 5-Fluorouracil for Actinic Keratosis Treatment and Chemoprevention: A Randomized Controlled Trial. J Invest Dermatol. 2017 Jun;137(6):1367-1370. doi: 10.1016/j.jid.2016.12.029. No abstract available.

Results Reference

result

PubMed Identifier

28621489

Citation

Pomerantz H, Chren MM, Lew R, Weinstock MA; VA Keratinocyte Carcinoma Chemoprevention (VAKCC) Trial Group*. Validation and comparison of quality-of-life measures for topical 5-fluorouracil treatment: results from a randomized controlled trial. Clin Exp Dermatol. 2017 Jul;42(5):488-495. doi: 10.1111/ced.13089.

Results Reference

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PubMed Identifier

28500658

Citation

Korgavkar K, Weinstock MA, Lee KC; VAKCC Trial Group. Evaluation of photoaging scales in an elderly male population. J Eur Acad Dermatol Venereol. 2017 Nov;31(11):e489-e490. doi: 10.1111/jdv.14330. Epub 2017 Jun 20. No abstract available.

Results Reference

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PubMed Identifier

29241779

Citation

Leader NF, Means AD, Robinson-Bostom L, Telang GH, Wilkel CS, Weinstock MA; Veterans Affairs Keratinocyte Carcinoma Chemoprevention Trial group. Interrater reliability for histopathologic diagnosis of keratinocyte carcinomas. J Am Acad Dermatol. 2018 Jan;78(1):185-187. doi: 10.1016/j.jaad.2017.07.024. No abstract available.

Results Reference

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PubMed Identifier

28877312

Citation

Korgavkar K, Lee KC, Weinstock MA; Veterans Affairs Keratinocyte Carcinoma Chemoprevention (VAKCC) Trial Group. Effect of Topical Fluorouracil Cream on Photodamage: Secondary Analysis of a Randomized Clinical Trial. JAMA Dermatol. 2017 Nov 1;153(11):1142-1146. doi: 10.1001/jamadermatol.2017.2578.

Results Reference

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PubMed Identifier

30508548

Citation

Means AD, Lee KC, Korgavkar K, Swetter SM, Dellavalle RP, Chen S, Stricklin G, Weinstock MA; Veterans Affairs Keratinocyte Carcinoma Chemoprevention (VAKCC) Trial Group. Development of a Pigmented Facial Lesion Scale Based on Darkness and Extent of Lesions in Older Veterans. J Invest Dermatol. 2019 May;139(5):1185-1187. doi: 10.1016/j.jid.2018.11.017. Epub 2018 Nov 30. No abstract available.

Results Reference

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PubMed Identifier

30896781

Citation

Beatson M, Means AD, Leader NF, Robinson-Bostom L, Weinstock MA. Characteristics of Keratinocyte Carcinomas and Patients with Keratinocyte Carcinomas Following a Single 2-4 Week Course of Topical 5-fluorouracil on the Face and Ears. Acta Derm Venereol. 2019 Jun 1;99(7):707-708. doi: 10.2340/00015555-3176. No abstract available.

Results Reference

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PubMed Identifier

31647464

Citation

Beatson M, Siegel JA, Chren MM, Weinstock MA. Effects of increased actinic keratosis count on skin-related quality of life: results from the Veterans Affairs Keratinocyte Carcinoma Chemoprevention (VAKCC) Trial. Eur J Dermatol. 2019 Oct 1;29(5):507-510. doi: 10.1684/ejd.2019.3637.

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32880186

Citation

Beatson M, Misitzis A, Landow S, Yoon J, Higgins HW 2nd, Phibbs C, Weinstock MA. Predictors of Basal Cell Carcinoma and Implications for Follow-Up in High-Risk Patients in the Veterans Affairs Keratinocyte Carcinoma Chemoprevention (VAKCC) Trial. J Cutan Med Surg. 2021 Jan-Feb;25(1):102-103. doi: 10.1177/1203475420945230. Epub 2020 Sep 3. No abstract available.

Results Reference

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PubMed Identifier

33047438

Citation

Misitzis A, Stratigos AJ, Beatson M, Mastorakos G, Dellavalle RP, Weinstock MA; Veterans Affairs Keratinocyte Carcinoma Chemoprevention Trial Group. The association of metformin use with keratinocyte carcinoma development in high-risk patients. Dermatol Ther. 2020 Nov;33(6):e14402. doi: 10.1111/dth.14402. Epub 2020 Oct 20.

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PubMed Identifier

27543222

Citation

Siegel JA, Chren MM, Weinstock MA; Department of Veterans Affairs Keratinocyte Carcinoma Chemoprevention Trial Group. Correlates of skin-related quality of life (QoL) in those with multiple keratinocyte carcinomas (KCs): A cross-sectional study. J Am Acad Dermatol. 2016 Sep;75(3):639-642. doi: 10.1016/j.jaad.2016.05.008. No abstract available.

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PubMed Identifier

27465252

Citation

Yoon J, Phibbs CS, Chow A, Pomerantz H, Weinstock MA. Costs of Keratinocyte Carcinoma (Nonmelanoma Skin Cancer) and Actinic Keratosis Treatment in the Veterans Health Administration. Dermatol Surg. 2016 Sep;42(9):1041-7. doi: 10.1097/DSS.0000000000000820.

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PubMed Identifier

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Citation

Weinstock MA, Thwin SS, Siegel JA, Marcolivio K, Means AD, Leader NF, Shaw FM, Hogan D, Eilers D, Swetter SM, Chen SC, Jacob SE, Warshaw EM, Stricklin GP, Dellavalle RP, Sidhu-Malik N, Konnikov N, Werth VP, Keri JE, Robinson-Bostom L, Ringer RJ, Lew RA, Ferguson R, DiGiovanna JJ, Huang GD; Veterans Affairs Keratinocyte Carcinoma Chemoprevention Trial (VAKCC) Group. Chemoprevention of Basal and Squamous Cell Carcinoma With a Single Course of Fluorouracil, 5%, Cream: A Randomized Clinical Trial. JAMA Dermatol. 2018 Feb 1;154(2):167-174. doi: 10.1001/jamadermatol.2017.3631.

Results Reference

derived

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CSP #562 - The VA Keratinocyte Carcinoma Chemoprevention Trial

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