Skin Aging
Conditions
Interventions
This is a randomized, retrospective, comparative, parallel, triple-blind clinical study of therapeutic intervention. Forty-one participants (men and women), over 50 years old, with advanced photoaging
Sponsors
Escola Paulista de Medicina/Universidade Federal de São Paulo - UNIFESP
Escola Paulista de Medicina/Universidade Federal de São Paulo - UNIFESP
Eligibility
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: Male or female; over 50 years; phototypes I to III, according to Fitzpatrick Scale; forearms with clinical diagnosis of severe or advanced photoaging, associated with actinic keratosis; agreement to avoid photoexposure during the period of therapy; ability to understand and strictly respect the guidelines provided; availability for periodic visits
Exclusion criteria
Exclusion criteria: Smokers; including indirect smokers; or former smokers, who stopped smoking for at least two years; topical treatments with tretinoin less than six months and other retinoids, alphahydroxy acids, polyhydroxy acids, betahydroxy acids and ascorbic acid less than three months; treatment with superficial chemical peels; microdermabrasion and fractional lasers less than three months; oral retinoid less than six months; history of hypersensitivity to parabens; infectious or inflammatory dermatoses diagnosed on the arms; previous chemotherapy or radiotherapy treatment; clinical evidence of immunosuppression; presence or history of photodermatosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome was to evaluate and compare the treatment improvement in the actinic keratosis counting at baseline and after treatment (eight weeks after the end of treatment) and between groups;The primary outcome was to evaluate and compare the treatment improvement in the Forearm Photoaging Scale at baseline and after treatment (eight weeks after the end of treatment) and between groups | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find an improvement in the assessment of hydration and skin visco-elasticity in both groups between pre and post treatments, according to the applied non-invasive instrumental measurements of corneometry (hydration) and cutometry (visco-elastic properties) respectively and compare whether there was superiority of one treatment over the other;It is expected to find a decrease in gene expression of TP53 and MKI67 genes after treatment in both groups and to evaluate whether there was a greater variation in one treatment in relation to the other;It is expected to find lower intensity of topical adverse events with high pressure homogenization 5-fluorouracil treatment when compared to traditional 5-fluorouracil treatment.;It is expected to find an improvement in the histological analysis in both groups between pre and post-treatments, according to the analysis of the epidermis and horny layer thickness, KIN (Keratinocyte Intraepidermal Neoplasia) classification, variation in the collagen and elastic fibers density and imunohistochemistry (p53 and Ki-67 markers); and compare whether there was superiority of one treatment over the other | — |
Countries
Brazil
Contacts
Public ContactNatalia Mestnik
Universidade Federal de São Paulo - UNIFESP
Outcome results
None listed