Administration, Intravaginal
Conditions
Interventions
An initial medical evaluation will be performed - by dermatologist Dr. Leila David Bloch (CRM: 108.287) in the 5 evaluable participants
After 03 weeks (21 ± 2 days) of use of the product, participants
Other
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 skin reactions (pigmentation disorders, vascular malformations, scars, increased hairiness, ephelides and nevus in large quantities, sunburn); 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) o Topical use with corticosteroids in the experimental area up to 8 days before the start of the study. 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 to use products from the same category as the product tested in the experimental region.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Verify the acceptability of the investigational product in the studied population, after the use of the product under real conditions, ensuring the product safety community. | — |
Secondary
| Measure | Time frame |
|---|---|
| The discomfort sensations and clinical signs of each participant will be evaluated, and according to the criteria determined by the gynecologist and dermatologist, the product will be considered dermato and gynecologically safe. | — |
Countries
Brazil
Contacts
Public ContactCassiano Escudeiro
Ipclin - Pesquisa Clínica Integrada
Outcome results
None listed