Radiodermatitis
Conditions
Interventions
Participants received two pots for daily application in the distal region of the forearm. One pot identified as right forearm and the other identified as left forearm. The pots contained the same form
Other
Sponsors
Escola de Enfermagem de Ribeirão Preto da Universidade de São Paulo
Faculdade de Ciências Farmacêuticas de Ribeirão Preto
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Healthy volunteers; older than 18 years; with integrity skin in sites for the application of products; no history of allergic reactions to shrimp, fish or seafood; no history of allergic reactions to any component of chamomile; no history of allergic reactions to components of the formulations.
Exclusion criteria
Exclusion criteria: Volunteers in current treatment with heparin, oral anticoagulants and antiplatelet agents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: Absence of erythema, peeling, itching, burning and pain at the site of application of the formulation during the period of 28 days, assessed by clinical evaluation and objective measurement with Mexameter® MX18 (Courage and Khazaka Electronics Ltd, Koln, Germany).;Outcome 1: The hypothesis that the lanolin formulation, containing Chamomilla recutita (L.) rauschert microparticles coated with chitosan would be safe for application to the intact skin of healthy volunteers was confirmed. Despite an isolated case of erythema, this event was not observed in other participants. There was alteration in melanin, attributed as protective effect of the formulation. There was no desquamation; one participant reported pain, with spontaneous and brief regression. The formulation did not cause pruritus or burning in the analyzed period | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2: Increased hydration and skin barrier function assessed by clinical evaluation and objective measurement with Corneometer® CM 825 (Courage & Khazaka, Koln, Germany) and Tewameter® TM 210 (Courage and Khazaka Electronics Ltd, Koeln, Germany). Expected to increase by at least 10% of hydration and improved barrier function.;Outcome 2: The results showed an improvement in skin hydration at the application site of the formulation with chamomile; the subjective evaluation of the sensation of hydration by the volunteers at the end of the period was positive in all evaluated sites. | — |
Countries
Brazil
Outcome results
None listed