Actinic Cheilitis Pre-Treated With DNA Repair Enzyme Cream

It is well known that ultraviolet (UV) light causes sunburn and DNA damage that can lead to skin cancer. Despite preventative measures of sunscreens and other topicals the incidence of skin cancers continues to increase every year. Chronic exposure can lead to development of both basal and squamous cell carcinoma that also is correlated to the risk of melanoma. When epidermal keratinocytes are exposed to UV radiation, they form cyclobutane pyrimidine dimmers (CPDs), 6-pyrimidine-4-pyrimidones (6-4-PPs), and oxygen radicals that alter the structure of nucleotides. When these lesions are not repaired, DNA replication is altered that leads to mutations in p53 and PTCH tumor suppressor gene and ultimately tumor development. It has been discovered that intracellular delivery of bacterial DNA incision repair enzyme T4 endonuclease V DNA repair enzymes can repair sun induced damaged DNA in patients with xeroderma pigmentosum4,. Yarosh et al also showed that T4 endonuclease V DNA repair enzymes are specific to reducing the amount of cyclobutane pyrimidine dimers and were found to lower the rate of new actinic keratoses compared to placebo lotion by 68% with no adverse effects observed. Additionally Yarosh et al also showed that T4N5 liposomes can repair keratinocyte DNA in skin cancer patients. This study will examine if pretreating actinic cheilitis with DNA repair enzyme cream before standard treatments can decrease the need for additional and possibly more aggressive therapies, decrease the surface area of affected areas, and possibly improve skin thickening and texture.

Study Overview

• Status: Withdrawn
• Conditions: Actinic Cheilitis
• Intervention / Treatment: Other: DNA Repair Enzyme Cream

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • La Grange Park, Illinois, United States, 60526
      • Loyola Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years or older with clinically confirmed actinic cheilitis
• Fitzpatrick Type I, II, III, or IV skin.
• At least 20% of upper and/or lower lip affected by actinic cheilitis

Exclusion Criteria:

• Pregnant or nursing
• Allergies to any component of the study topical medication
• Prior treatment of actinic cheilitis within the past month, including cryotherapy, PDT, 5-FU, Picato, Retinoid, Diclofenac
• Prior ablative laser therapy to the lips, including fractional erbium and CO2 lasers.
• Prior use of lip fillers
• Presence of any skin disease that might interfere with the study treatments, including, but not limited to, rosacea, atopic dermatitis, lip lickers dermatitis, perioral dermatitis, perleche, active herpes infection.
• Presence of hypertrophic and hyperkeratotic lesions or cutaneous horns within the treatment area
• Any diagnosis of active, untreated skin cancer of the lip

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Actinic Cheilitis patients	Other: DNA Repair Enzyme Cream; ver-the-counter cosmeceutical. We were going to be using it adjunctively before standard treatment of the actinic cheilitis was done

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of complete clearance vs partial response, determined clinically and by high-resolution macrophotography through blinded dermatologist evaluation	Percentage of patients with no clinically visible remaining lesions in treated area For partial responders: differentiate approximate surface area of affected lips, expressed as a percentage (0 to 100), compared with that prior to treatment	12 weeks

Collaborators and Investigators

• Sponsor: Loyola University

Publications and helpful links

General Publications

• Yarosh D, Klein J, O'Connor A, Hawk J, Rafal E, Wolf P. Effect of topically applied T4 endonuclease V in liposomes on skin cancer in xeroderma pigmentosum: a randomised study. Xeroderma Pigmentosum Study Group. Lancet. 2001 Mar 24;357(9260):926-9. doi: 10.1016/s0140-6736(00)04214-8.
• de Berker D, McGregor JM, Hughes BR; British Association of Dermatologists Therapy Guidelines and Audit Subcommittee. Guidelines for the management of actinic keratoses. Br J Dermatol. 2007 Feb;156(2):222-30. doi: 10.1111/j.1365-2133.2006.07692.x. Erratum In: Br J Dermatol. 2008 Apr;158(4):873.
• Mouret S, Baudouin C, Charveron M, Favier A, Cadet J, Douki T. Cyclobutane pyrimidine dimers are predominant DNA lesions in whole human skin exposed to UVA radiation. Proc Natl Acad Sci U S A. 2006 Sep 12;103(37):13765-70. doi: 10.1073/pnas.0604213103. Epub 2006 Sep 5.
• Cleaver JE. Defective repair replication of DNA in xeroderma pigmentosum. 1968. DNA Repair (Amst). 2004 Feb 3;3(2):183-87.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): January 31, 2018

Study Registration Dates

• First Submitted: July 19, 2017
• First Submitted That Met QC Criteria: July 19, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): January 12, 2018
• Last Update Submitted That Met QC Criteria: January 10, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Cheilitis
• Other Study ID Numbers: 210079

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No