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Actinic Cheilitis Pre-Treated With DNA Repair Enzyme Cream

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03224715
Recruitment Status : Withdrawn (Project was withdrawn and never began at Loyola University Medical Center.)
First Posted : July 21, 2017
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Rebecca Tung, 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.

Condition or disease Intervention/treatment Phase
Actinic Cheilitis Other: DNA Repair Enzyme Cream Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Actinic Cheilitis Pre-Treated With DNA Repair Enzyme Cream
Estimated Study Start Date : September 1, 2017
Estimated Primary Completion Date : December 1, 2017
Estimated Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Rate of complete clearance vs partial response, determined clinically and by high-resolution macrophotography through blinded dermatologist evaluation [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03224715


Locations
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United States, Illinois
Loyola Dermatology
La Grange Park, Illinois, United States, 60526
Sponsors and Collaborators
Loyola University
Publications:
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Responsible Party: Rebecca Tung, Director of Dermatology, Loyola University
ClinicalTrials.gov Identifier: NCT03224715    
Other Study ID Numbers: 210079
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cheilitis
Lip Diseases
Mouth Diseases
Stomatognathic Diseases