EUCTR2015-005820-24-IT
Active, not recruiting
Phase 1
A randomized study to evaluate the efficacy of ingenol mebutate on actinic keratoses and field cancerization compared to cryotherapy - A study to evaluate the efficacy of ingenol mebutate on precancerosis and its contigous area compare
A.O.U. Università degli Studi della Campania Luigi Vanvitelli0 sites50 target enrollmentJune 1, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- actinic keratoses and field cancerization
- Sponsor
- A.O.U. Università degli Studi della Campania Luigi Vanvitelli
- Enrollment
- 50
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Current diagnosis of AK, with \=2 lesions of grade I and/or II located in two different anatomical districts (within a contiguous 25 cm2 area on the face, scalp or forehead);
- •\- Male \= 18 years of age
- •\- Female \= 60 years of age ;
- •Skin type I or II according to Fitzpatrick;
- •Patient has confirmed his/her willingness to participate in this study after being informed of all aspects of the study that are relevant to his/her decision to participate, by signing and dating the approved informed consent form, according to ICH and local laws.
- •The 25 cm2 contiguous treatment areas could be of any shape, e.g. 5 cm x 5 cm, 2 cm x 12\.5 cm, 3 cm x 8\.3 cm.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 30
Exclusion Criteria
- •Has received any therapy for AK within the past 3 months
- •Has AK of grade III
- •Has currently a skin cancer or shows an early stage of skin cancer;
- •Has another skin disease that requires treatment with other medications in the AK area or in distance of 3 cm;
- •Use of cosmetic or therapeutic products and procedures which could interfere with assessments of the treatment area;
- •Immunosuppressive therapies or current treatment for cancer;
- •Clinically unstable medical condition;
- •High risk group for HIV infection or presentation of other infectious diseases (HAV, HBV, HCV, TBC, etc);
- •Allergies to the tested gel (ingenol mebutate and eccipients);
- •Pregnancy and breastfeeding;
Outcomes
Primary Outcomes
Not specified
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