Chronic Venous Insufficiency
Conditions
Interventions
46 female volunteers should be applied 2 or 3 times a day, for 4 week, this lotion in legs and feet doing light massage. The evaluation will be done only intra-group, without a control group.
Other
Sponsors
Medcin Instituto da Pele
Farmoquimica S.A
Eligibility
Sex/Gender
Female
Age
35 Years to 65 Years
Inclusion criteria
Inclusion criteria: Volunteer female; aged 35-65 years with a history of Chronic Venous Insufficiency; with complaints of episodes of edema, fatigue and heaviness in the legs and feet, agreement to abide by the procedures of the trial and attend the clinic in the days and schedules determined for the application and readings and Signing the consent form
Exclusion criteria
Exclusion criteria: Pregnant; lactating or planning to become pregnant during the study period; use of the following drugs of topical or systemic use immunosuppressants, antihistamines, NSAIDs, and corticosteroids within 30 days before the selection or considering immunosuppressants, the interval should be 3 months before screening; atopic or allergic to cosmetics history; pathologies and / or active skin lesions in the area of review (local and or / disseminated); skin marks in the experimental area that interfere with evaluation of possible skin reactions (vascular malformations, scars, increasing hairiness, nevus aplenty, sunburn); diseases which cause immune suppression, such as diabetes, HIV; endocrine disorders such as thyroid, ovarian or adrenal gland disorders; volunteers with congenital or acquired immunodeficiency known; relevant medical history or current evidence of alcohol or other drugs; History known or suspected intolerance to products of the same category; intense sun exposure up to 15 days before evaluation; or dermatological aesthetic treatment in the assessment area up to 04 weeks before screening; professionals directly involved in the study design; other conditions considered by the medical examiner as reasonable for disqualification from participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical improvement of tired legs and feet within 30 days after application of 2 or 3 times the cosmetic lotion verified by clinical and subjective evaluations from the observation of improvement in dry skin, skin induration and edema of the legs and aspect feet as well as reducing itching, heaviness in the legs, sensation of "burning" in the legs, feeling of tiredness in the legs, swelling of perception in the legs and feet in the days 15 and 30;In 15 e 30 days after application of 2 or 3 times the cosmetic lotion verified, by clinical evaluations, the improvement in dry skin, skin induration and edema aspect of the legs and feet. Furthermore, the subjective evaluation, found a improvement of the itching, heaviness in the legs, sensation of "burning" in the legs, feeling of tiredness in the legs, swelling of perception in the legs and feet | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety the cosmetic lotion verified through reported adverse events after administration of the product;The product has proved to be safe in use conditions, not observing none adverse events or referred to during use. | — |
Countries
Brazil
Contacts
Public ContactFlávia Sant’Anna Addor
Medcin Instituto da Pele
Outcome results
None listed