A prospective, randomized, monocentric, rater blinded study evaluating the change of the cutaneous microbiome in correlation to the efficacy of cold atmospheric plasma treatment in comparison to diclofenac 3% in 2.5% hyaluronic acid (Solaraze 3% Gel®) in patients with actinic keratoses
- Conditions
- D04Carcinoma in situ of skin
- Registration Number
- DRKS00012714
- Lead Sponsor
- niversitätsklinikum Essen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
• Subjects must provide informed consent
• Subjects must be = 18 years of age on the day of signing informed consent.
• Subjects with two anatomically comparable areas with each containing = 2 clinically significant AK
• Female subjects of childbearing potential must be willing to consent to use highly effective methods of contraception (since the use of Solaraze Gel® is contraindicated during the last trimenon)
• Known sensitivity or allergy to diclofenac or any of the ingredients in Solaraze Gel®
• Current enrollment or participation in other clinical trial
• Known history of photodermatitis or porphyria
• Inability to apply UV protection measures
• Female subjects who are pregnant or breastfeeding
• Dementia or mental retardation
• The subject is unlikely to comply with the Clinical Study Protocol
• Clinical suspicion of invasive tumors within the treatment areas or skin disorders that could either be worsened by the study treatment or interfere with treatment evaluation
• Concomitant therapy for actinic keratosis in STA other than the study medication
• Any of the prohibited medication and procedures described in trial protocol
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Evaluation of the microbiome before, during and after the treatment with cold atmospheric plasma in comparison to diclofenac 3% in 2.5% hyaluronic acid (Solaraze 3% Gel®)<br>- Clinical clearance of AKs (actinic keratosis) in the treatment field after 90 days<br>
- Secondary Outcome Measures
Name Time Method - Histologic response of target lesions after 90 days of therapy as compared to baseline using routine H&E staining of FFPE sections<br>- Safety and tolerability will be documented and classified after 1, 2, 4, 8, and 12 weeks (or if the patient is reporting adverse events in the meantime) according to the LSRS score (Rosen et al., Dermatol Ther 2014)<br>- Cosmetic outcome will be determined after 90 days of treatment using the cosmetic outcome score established by Reinhold et al. Br J Dermatol 2016.