atural medicine made from black pickle and saffron as an alternative treatment for actinic cheilitis

Not Applicable

Recruiting

• Conditions: Actinic cheilitis (AC) is a potentially malignant disorders of the oral mucosa (PMD) that occurs on the lip dua to excessive and cronic exposure to ultraviolet rays present in sunlight. This condition can progress to squamous cell carcinoma and the clinical characteristics of AC include atrophy of the vermilion border of the lip; pigmented,erythematous, or eukoplakic areas; loss of the mucocutaneous junction of the lip; fissures and erosions that can bleed; and symptoms of dryness and pain.DeCS: stomatognathic diseases; mouth diseases.; C07.465

• Registration Number: RBR-9t6jgv
• Lead Sponsor: Faculdade de Odontologia - Universidade Federal de Goiás

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-04
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients with actinic cheilitis lesions who can cooperate and who agreed to participate in the study signed the free informed consent form

Exclusion Criteria

Patients who don´t agreed to participate in the study signed the free informed consent form; allergic to any component of the formulation; immunocompromised patients and those exhibiting ulcerated areas, nodularity, and bleeding in the lip that could suggest progression of SCC; and patients using medications in the target area

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
It is hoped to find improvement of the clinical signs of actinic cheilitis in the patients of the experimental group who make use of the phytotherapic. This will be verified from a photographic evaluation of the lips before and after treatment, which will receive scores according to their clinical aspect: 1 - complete improvement; 2 - partial improvement; 3 - no change; 4 - worsening of the clinical condition

Secondary Outcome Measures

Name	Time	Method
To evaluate the patient's tolerability to the drug and its satisfaction after treatment. It will be evaluated with questionnaire adapted from the study of Nelson, Spencer, and Nelson, applied at the end of treatment using a 5-point scale of responses, where 0 = I neither agree nor disagree; 1 = I slightly agree; 2 = I completely agree; 3 = I slightly disagree; and 4 = I completely disagree, to the following statements: (a) My lip lesions have improved with this product; (b) This product does not cause irritation to the lips; (c) I am satisfied with this product