Actinic Cheilitis
Conditions
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.
Interventions
OTHERDNA Repair Enzyme Cream
ver-the-counter cosmeceutical. We were going to be using it adjunctively before standard treatment of the actinic cheilitis was done
Sponsors
Loyola University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed