Rectal absorption
Conditions
Interventions
An initial medical evaluation will be performed - by dermatologist Dr. Leila David Bloch (CRM: 108.287), gynecologist and proctologist - at the time of inclusion of 30 participants avaliables to verif
will be classified as intensity as: mild, moderate or intense
as for location
and as to the duration
and the imputability to the test product will be verified.
Clinical signs: will be reported (example: erythema, edema, gallbladder, blister, papule, crust, dryness, discromy, macula). The intensities
Other
E02.319.267.120.655.750
Sponsors
Labterapi Laboratório de produtos naturais EIRELI EPP
Labterapi Laboratório de produtos naturais EIRELI EPP
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Women; Age 18 to 65 years; Phototype I to IV; Whole skin of the region; Occasional user of category products
Exclusion criteria
Exclusion criteria: Skin markings in the experimental area that interfere with the evaluation of possible reactions; Pregnant or lactating women; Participants with a history of allergy to the material used in the study; History of atopy; Use of vaginal cream; Participants with a history of allergy to products of the tested category; Recent gynecological surgeries; Discharge; Carriers of immunodeficiencies; Kidney, cardiac or liver transplantation; Active skin conditions that may interfere with the study (vitiligo, psoriasis, lupus, atopic dermatitis); Topical use with corticosteroids in the experimental area up to 8 days before study start; Any condition not mentioned above that, in the opinion of the investigator, may compromise the evaluation of the study. Note: Participants included are advised not to change their diet, exercise routine and contraceptive method. Also, not using products in the same category as the product tested in the experimental region
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improved anal hydration can prevent possible injuries; It is expected to verify the acceptability of the investigational product in the population studied. | — |
Secondary
| Measure | Time frame |
|---|---|
| After using the product under real conditions, if there is no causal link, it will be ensuring the community the safety of the product. | — |
Countries
Brazil
Contacts
Public ContactCassiano Escudeiro
Ipclin - Pesquisa Clínica Integrada
Outcome results
None listed