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Assessment of proctological, gynecological and dermatological acceptability using the product at home

Evaluation of the proctological , gynecological and dermatological acceptability of a health product under normal conditions of use_MAKE03.2022

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8n2y6sq
Enrollment
Unknown
Registered
2023-02-22
Start date
2023-04-20
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

healthy volunteers

Interventions

Sponsors

Ipclin Instituto de Pesquisa Clínica Integrada Ltda
Lead Sponsor
Makelife Comercio Atacadista e Varejista LTDA
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 59 Years

Inclusion criteria

Inclusion criteria: Gender: female; Age: 18 to 59 years; Phototype: I to IV; Intact skin in the region; Occasional user of products in the category

Exclusion criteria

Exclusion criteria: Skin marks in the experimental area that interfere with the evaluation of possible chemical reactions (pigmentation disorders, vascular malformations, scars, increased hairiness, freckles and nevus in large numbers, sunburn); Pregnant or lactating women; Participants with a history of allergies to the material used in the study; History of atopy; Use of vaginal cream; Participants with a history of allergies to cosmetic products in the test category; Recent gynecological surgeries; discharges; People with immunodeficiencies; Kidney, heart or liver transplants; Active cell pathologies that may interfere with the study (vitiligo, psoriasis, lupus, atopic dermatitis); Topical use with corticoid in the experimental area up to 8 days before the beginning of the study. Any condition not mentioned above which, in the opinion of the investigator, may compromise the study evaluation Note: the participants included are instructed not to change their diet, exercise routine and contraceptive method. Also, do not use products from the same category as the product tested in the experimental region.

Design outcomes

Primary

MeasureTime frame
It is expected to verify the acceptability of the investigational product in the studied population, after using the product in real conditions, guaranteeing the safety of the product to the community.

Secondary

MeasureTime frame
It is expected to guarantee to the final users the safety of the product, an intimate lubricant, from the verification that none of the participants presented discomfort or clinical signs

Countries

Brazil

Contacts

Public ContactCassiano Escudeiro

Ipclin Instituto de Pesquisa Clínica Integrada Ltda

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

Outcome results

None listed

Source: REBEC (via WHO ICTRP)