qualified volunteers
Conditions
Interventions
This is a clinical study to evaluate the gynecological and dermatological safety of a health product. The inclusion of 35 female participants, aged 18 to 65 years and phototypes I to IV (according to
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 old; 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 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
Secondary
| Measure | Time frame |
|---|---|
| After 3 weeks (21 ± 2 days) of use of the product, participants will return to the Institute for the final medical evaluation of the clinical signs presented and questioning the feelings of discomfort felt. Medical evaluation data will be recorded in the research book. The dermatologist and gynecologist will be available throughout the study to evaluate possible adverse events. | — |
Primary
| Measure | Time frame |
|---|---|
| It is expected to verify the acceptability of the investigational product in the population studied after the use of the product under real conditions, ensuring the safety of the product to the community. An initial medical evaluation will be performed - by dermatologist Dr. Leila David Bloch (CRM: 108.287), the gynecologist and the researcher responsible - at the time of inclusion of participants to verify the absence of initial clinical signs incompatible with their inclusion. Results will be evaluated as follows: Feelings of discomfort: Participants will be asked about the feelings of discomfort felt in parallel with the clinical examination. The reported feelings of discomfort will be described in relation to nature (eg burning, pinching, itching, tugging, cooling, warming, etc.); 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 classified according to Table 2 and the causal link of reactions to the product will be investigated. The discomfort sensations and clinical signs of each participant will be evaluated, and the responsible gynecologist and dermatologist will determine, based on what is observed, whether or not the product can be considered as gynecologically and dermatologically safe. | — |
Countries
Brazil
Contacts
Public ContactCassiano Escudeiro
Ipclin - Pesquisa Clínica Integrada
Outcome results
None listed