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Evaluation of Gynecological and Dermatological Acceptability of Health Products using the product at home.

Evaluation of Gynecological and Dermatological Acceptability of Health Products under Normal Conditions of Use

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-5fjcmr
Enrollment
Unknown
Registered
2020-07-30
Start date
2020-08-24
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Administration Intravaginal

Interventions

as to the location
and as for the duration
Dermatological and Gynecological Medical Evaluation of Clinical Signs and Sensations Discomfort An initial medical evaluation - by dermatologist Dr. Leila David Bloch (CRM: 108.287), by the gynecologi
will be classified according to intensity as: mild, moderate or intense
and the imputability to the test product will be verified.
Other
G03.015.500.937

Sponsors

Makelab Consultoria Eireli
Lead Sponsor
Makelab Consultoria Eireli
Collaborator

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 marks in the experimental area that interfere in the evaluation of possible reactions; Pregnant or lactating women; Participants with a history of allergy to the material used in the study; Background of atopy; Use of vaginal cream; Participants with a history of allergy to products in the tested category; Recent gynecological surgeries; Discharges; Immunodeficiency patients; Kidney, heart or liver transplantation; Active skin pathologies 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 investigator's opinion, may compromise the evaluation of the study. Note: the participants included are instructed not to change their diet, routine exercises and contraceptive method. Also, not to use products of the same category of the product tested in the experimental region.

Design outcomes

Primary

MeasureTime frame
It is expected to verify the acceptability of the investigated products in the studied population, after using the products in real use conditions.—

Secondary

MeasureTime frame
It is expected to guarantee to the community the safety of products.—

Countries

Brazil

Contacts

Public ContactCassiano Escudeiro

Ipclin - Pesquisa Clínica Integrada

cassiano@ipclin.com.br+55-011 4087-0092

Outcome results

None listed

Source: REBEC (via WHO ICTRP)