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Safety evaluation of cosmetic products by gynecologist and dermatologist in normal conditions of use

Gynecological and dermatological aceitabiity evaluation of cosmetics products in normal conditions of use

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-33z3x8
Enrollment
Unknown
Registered
2017-05-25
Start date
2016-05-26
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

Other specified noninflammatory disorders of vagina

Interventions

Sponsors

Avenca Indústria Cosmética
Lead Sponsor
Avenca Indústria Cosmética
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Female. Age 18 to 65 years. Phototype I to IV. Intact skin in the test area. Occasional user of the category products.

Exclusion criteria

Exclusion criteria: Cutaneous marks 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 women or infants. Subjects with a history of allergy to the material used in the study. History of atopy. Use of vaginal cream. Subjects with a history of allergy to cosmetic products of the tested category. Recent gynecological surgeries. Vaginal discharge. Immunodeficiency carriers. Renal, cardiac or hepatic transplanted. Active cutaneous pathologies that may interfere with the study (vitiligo, psoriasis, lupus, atopic dermatitis). Topical use of corticosteroids in the experimental area up to 8 days before the start of the study.

Design outcomes

Primary

MeasureTime frame
It is expected to verify the acceptability of the research product in the studied population, after the use of the product in real conditions, guaranteeing to the community the safety of the product. The sensations of discomfort and clinical signs of each participant will be evaluated by a dermathologist and, if at least 70% of them do not report / show feelings of discomfort / clinical signs, the product will be considered dermato and gynecologically safe;The dermatological and gynecological safety of the product was attested. No study subject presented sensations of discomfort or clinical signs.

Secondary

MeasureTime frame
Through the perception of the subjects it is shown that the use of the product offers benefits of lubrication and quality of the sexual act and is therefore recommended for women who present reduction of natural vaginal lubrication and / or complaints of dyspareunia

Countries

Brazil

Contacts

Public ContactCassiano Escudeiro

Ipclin - Pesquisa Clínica Integrada

cassiano@ipclin.com.br+55 (11) 4497 - 1315

Outcome results

None listed

Source: REBEC (via WHO ICTRP)