Effectiveness and tolerance of Deep Peeling compared to Imiquimod cream in the treatment of Actinic Cheilitis

Not Applicable

• Conditions: Diseases of the lips; Actinic keratosis; K13.0

• Registration Number: RBR-1044sz68
• Lead Sponsor: ESP - Universidade Estadual Paulista

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-19
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Sign the Informed Consent Form; age over 18 years of both sexes; present histological diagnosis of QA in the lower lip.

Exclusion Criteria

Phototypes V and VI; selected treatment area that has atypical clinical appearance or other dermatoses; current and previous clinical diagnosis or evidence of any medical condition that exposes the patient to increased risks, interferes with the safety or efficacy of the proposed treatment; present current or previous diagnosis of CPB on the lower lip; present hypersensitivity or allergy to any of the substances under study; any treatment for QA in the last 8 weeks except photoprotection; suspected or confirmed pregnancy; women of childbearing potential who do not use contraception; women who are breastfeeding.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
It is expected to find a complete clearance rate of QAs at D60 verified by histopathological analysis and we will observe a variation of at least 15% in the measurements between the treatment groups.

Secondary Outcome Measures

Name	Time	Method
Evaluate the clinical improvement of the lower lip by comparing D0 with D60 by checking clinical evaluation by photographs and dermoscopic evaluation.;Evaluate epithelial dysplasia using the KIN evaluation method by comparing D0 with D60, observing the histological improvement.;Evaluate adverse effects related to the proposed treatments, incidence of local events and severity by actively asking for possible effects (bleeding, pain, burning, numbness, discomfort in eating, hypertrophic scars after the procedure).;Assess tolerability through subjective preference to any of the proposed treatments.