Actinic Cheilitis Pre-Treated With DNA Repair Enzyme Cream

Not Applicable

Withdrawn

• Conditions: Actinic Cheilitis
• Interventions: Other: DNA Repair Enzyme Cream

• Registration Number: NCT03224715
• Lead Sponsor: Loyola University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-19
• Study First Submitted QC: 2017-07-19
• Study First Posted: 2017-07-21
• Study Start: 2017-09-01
• Primary Completion: 2017-12-01
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-10
• Last Update Posted: 2018-01-12
• Study Completion: 2018-01-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Actinic Cheilitis patients	DNA Repair Enzyme Cream	-

Primary Outcome Measures

Name	Time	Method
Rate of complete clearance vs partial response, determined clinically and by high-resolution macrophotography through blinded dermatologist evaluation	12 weeks	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

Trial Locations

Locations (1)

Loyola Dermatology; 🇺🇸 La Grange Park, Illinois, United States