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Evaluation of the Efficacy and Safety of a product for health, through the Evaluation of a Dermatologist and Application of Questionnaire

Evaluation of subjective dermatological clinical efficacy and safety with healthcare product appreciability_TCI

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9bb2pt
Enrollment
Unknown
Registered
2018-04-17
Start date
2018-04-05
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

Contact dermatitis

Interventions

Experimental group: 18 participants, of both sexes, aged 18 to 65 years and phototypes of I to IV (according to Fitzpatrick's classification), susceptible to the appearance of contact wound and / or d
Device
Genetics

Sponsors

Ipclin - Pesquisa Clínica Integrada
Lead Sponsor
TCI Laboratório Biotecnológico LTDA.
Collaborator

Eligibility

Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age between 18 to 65 years; Female or male; Phototypes I to IV; Subjects susceptible to the appearance of wound and/or contact dermatitis; Able to follow the guidelines and reliable to respect the restrictions of the protocol.

Exclusion criteria

Exclusion criteria: Skin 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); 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; Participants with a history of allergy to the material used in the study; History of atopy; History of conditions aggravated or triggered by ultraviolet radiation; Immunodeficiency carriers; Renal, cardiac or hepatic transplanted; Intense sun exposure or tanning session up to 15 days prior to initial assessment; Prediction of intense sun exposure or the tanning session during the period of study conduction; Forecast to take a bath, pool or sauna during the study; Participants who practice water sports; Use of the following topical systemic medications: immunosuppressants, antihistamines, non-hormonal anti-inflammatories, and corticosteroids up to two weeks prior to selection; Treatment with acid vitamin A and / or its derivatives orally or topically up to 01 month before the start of the study; Prediction of vaccination during the study or until 03 weeks before the study; Be participating in another study; Any condition not mentioned above that, in the opinion of the investigator, could compromise the evaluation of the study; History of absence of adherence or unwillingness to adhere to the study protocol; Professionals directly involved in the accomplishment of this protocol and their relatives.

Design outcomes

Primary

MeasureTime frame
Improvement in skin conditions, identified by counting of positive responses from research participants, after completing a questionnaire of appreciability and post-intervention medical evaluation.

Secondary

MeasureTime frame
Secondary outcomes are not expected.

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)