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Evaluation of irritability and sensitization of health products, through the contact test.

Assessment of primary skin irritability, accumulation and awareness of products for through the contact test.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-3k6982
Enrollment
Unknown
Registered
2020-06-03
Start date
2020-06-29
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

Test Product Application The products will be applied as it is on semi-occlusive dressings, with the aid of 1 mL disposable syringe. Distilled water will be used as a control. The dressings will be pl
Other

Sponsors

Makelab Consultoria Eireli
Lead Sponsor
Labterapi Laboratório de produtos naturais EIRELI EPP
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 products of the category

Exclusion criteria

Exclusion criteria: Participants who refuse to participate in the study in question; Skin marks in the experimental area that interfere in the evaluation of possible skin reactions; Active dermatoses (local and disseminated) that may interfere with the results of the study; Pregnant or lactating women; History of allergic reactions, irritation or intense feelings of discomfort to topical products: cosmetics and medicines; Volunteers 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; History of pathologies aggravated or triggered by ultraviolet radiation; Immunodeficiency sufferers; Kidney, heart or liver transplantation; Forecast of intense sun exposure or tanning session during the period conducting the study; Forecast of bathing in the sea, pool or sauna during the study; Participants who practice water sports; Use of the following medications for systemic topical use: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs, and corticosteroids up to two weeks before selection; Treatment with acidic vitamin A and / or its derivatives orally or topically up to 01 month before the beginning of the study; Vaccination forecast during the study or up to 03 weeks before the study; Any condition not mentioned above that, in the opinion of the investigator, could compromise the evaluation of the study.

Design outcomes

Primary

MeasureTime frame
It is hoped to prove the absence of primary skin irritation reactions and accumulated and allergic reactions by sensitization by investigative products.

Secondary

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

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)