MedPath

Effect and safety of 5% nicotinamide cream in the treatment of actinic keratosis

Not Applicable
Recruiting
Conditions
Actinic Keratosis
C04.834
Registration Number
RBR-6m7tyhf
Lead Sponsor
Faculdade de Medicina Julio de Mesquita Filho
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
Not specified
Inclusion Criteria

Sign the Free and Informed Consent Form; age over 18 years of both sexes; present at least three and at most ten lesions clinically compatible with actinic keratoses on each forearm, bilaterally.

Exclusion Criteria

Actinic keratoses fewer than three or more than ten on each forearm; selected treatment area that has atypical clinical appearance or other extensive dermatoses on the forearms; presence of skin tumors in the treatment area; 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 hypersensitivity or allergy to any of the substances being studied; patients using any systemic or topical immunosuppressant substance and oral retinoid; immunocompromised individuals; coagulation disorders; suspected or confirmed pregnancy; women of childbearing age not using contraceptive methods; breastfeeding women; previous treatments for actinic keratoses in the last six months.

Study & Design

Study Type
Intervention
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
An absence of new actinic keratoses on the forearms is expected after the application of 5% nicotinamide cream within a period of 70 days, which will be verified by counting the actinic keratoses, based on the verification of a variation of at least 15% in the pre and post measurements -intervention.<br>
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath