Actinic Keratosis
Conditions
Interventions
A randomized, double-blind, intrasubject ,placebo-controlled clinical trial will be conducted in which 80 immunocompetent individuals, without gender restriction, older than 18 years of age, with thre
the actinic keratoses count will be performed in duplicate, using skin marking, to ensure its reproducibility. Regarding blinding, both products will be white, of similar texture and will be packed i
Sponsors
Faculdade de Medicina Julio de Mesquita Filho
Fundo de Apoio à Dermatologia
Eligibility
Age
18 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find a reduction in the photoaging scale of the forearms after the application of nicotinamide 5% cream within 70 days, which will be verified by evaluating the number of superficial and hypertrophic actinic keratoses, amount and severity of rhytids, number of sun lentigines, purpura, atrophic scars, elastosis and loss of elasticity. A change of at least 15% in pre- and post-intervention measurements is expected.;It is expected to find a reduction in the number of actinic keratoses on the forearms after the application of 5% nicotinamide cream over 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 measurements and post-intervention. The severity score takes into account the number of lesions, the degree of erythema, hyperkeratosis, infiltration, and the diameter (measured in millimeters) of the skin lesions. Each criterion is graded from zero to three. The lesions are characterized individually and the values are added up.;Evaluate the severity score of actinic keratoses on the forearms after the application of 5% nicotinamide cream over a period of 70 days, which will be verified through the degree of erythema, hyperkeratosis, infiltration and diameter of actinic keratoses. Each criterion is graded from zero to three. Lesions are characterized individually and values are summed. A variation of at least 15% is expected in pre- and post-intervention measurements.;Evaluate the side effects and tolerability of the application of 5% nicotinamide cream over a period of 70 days, which will be verified through clinical observation of edema, scaling, ulceration or blisters and the presence of symptoms of itching, burning, dryness, irritation and burning . A variation of at least 5% is expected in pre- and post-intervention measurements. | — |
Countries
Brazil
Contacts
Public ContactIvanka Castro
Faculdade de Medicina Julio de Mesquita Filho
Outcome results
None listed