Skip to content

Evaluation of irritability and sensitization of cream for Psoriasis through the Contact Test

Assessment of primary skin irritability, accumulation and awareness of a health product (moisturizing cream for Psoriasis) through the Patch Test

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-2j4j5gr
Enrollment
Unknown
Registered
2021-09-16
Start date
2021-09-27
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

Psoriasis

Interventions

A survey will be conducted on 60 people of both sexes. 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 con

Sponsors

TCI BIOTECNOLOGIA LTDA
Lead Sponsor
TCI BIOTECNOLOGIA LTDA
Collaborator

Eligibility

Age
18 Years to 59 Years

Inclusion criteria

Inclusion criteria: Male and female; Age: 18 to 59 years; Phototype: I to IV; Whole skin of the area;

Exclusion criteria

Exclusion criteria: Participants who refuse to participate in the study; 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; Historic 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 of 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 expected to prove, trought the patch test, the absence of primary skin irritation reactions and accumulated and allergic reactions by sensitization by investigative products, if no participant reports/presents discomfort sensations/clinical signs.

Secondary

MeasureTime frame
It is hoped to guarantee the safety of the products to the community, through the patch test, if no participant reports/presents discomfort sensations/clinical signs.

Countries

Brazil

Contacts

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

Outcome results

None listed

Source: REBEC (via WHO ICTRP)