Chemexfoliation
Conditions
Interventions
This is a two-arm, double-blind, self-controlled, randomized clinical trial. Twenty individuals with a count of actinic keratoses on each forearm between 3 and 10 lesions were randomly selected to rec
application of two layers of Jessner's solution, with a 2-minute interval between applications, with an endpoint of bright erythema
subsequent application of 0.5% colchicine cream in a single layer or placebo on each forearm, without bandaging. The patient was instructed to remain at least six hours without washing the treated are
Sponsors
Sociedade Brasileira de Dermatologia Regional São Paulo - FUNADERSP
Sociedade Brasileira de Dermatologia Regional São Paulo - FUNADERSP
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Sign the Free and Informed Consent Form; Age over 18 years of age for both sexes; Present at least three and no more than ten lesions clinically compatible with actinic keratosis on each forearm, bilaterally
Exclusion criteria
Exclusion criteria: Less than three or more than ten lesions on each forearm; Use of any specific treatment for AKs and/or cutaneous cancerization in the last 6 months; Selected treatment area with an atypical clinical appearance or other extensive dermatoses on the forearms; Current and previous clinical diagnosis or evidence of any medical comorbidity that exposes the patient to increased risks, interferes with the safety or efficacy of the proposed treatment; Present hypersensitivity or allergy to any of the substances under study; Patients using any systemic or topical immunosuppressive substance, oral retinoid, in addition to other local treatments (e.g. corticosteroids, anti-inflammatories, retinoids); Immunocompromised individuals; Coagulation disorders; Suspected or confirmed pregnancy; Women who are breastfeeding; Refusal to undergo dermatological ultrasound
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A difference of 10% is expected between the groups in the complete clearance of actinic keratoses | — |
Secondary
| Measure | Time frame |
|---|---|
| A difference of 10% is expected between the groups in the partial clearance (>50%) of actinic keratoses ;A greater percentage reduction in actinic keratoses counts is expected in the group treated with colchicine;A greater percentage reduction in the photoaging scale of the forearms is expected in the group treated with colchicine;A greater improvement in the severity scale of actinic keratoses and in the ultrasound parameters of the worst actinic keratoses identified on day zero is expected in the group treated with colchicine | — |
Countries
Brazil
Contacts
Public ContactDaniel Amurim
Sociedade Brasileira de Dermatologia Regional São Paulo - FUNADERSP
Outcome results
None listed