NCT04248556

Brief Summary

This is a clinical study for health care product safety assessment. The research will be conducted with 92 subjects, aged 18 to 59 years. The product will be applied on the right and/or left back of the research participants for 3 consecutive weeks. After 10 days, will have another application of the same product, which will be removed in 48 hours. Medical evaluation will be available throughout the study to assess possible adverse events. The objective of the study is to observe the effects of the application of the product on the skin and prove the absence of irritability and/or allergy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 9, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2021

Completed
Last Updated

May 10, 2021

Status Verified

May 1, 2021

Enrollment Period

1 month

First QC Date

January 28, 2020

Last Update Submit

May 6, 2021

Conditions

Sensitivity, Contact

Outcome Measures

Primary Outcomes (1)

  • Absence

    Absence of the occurrence of reactions of primary, accumulated dermal irritation and of allergic reactions by sensitization by the investigational products.

    4 weeks

Study Arms (1)

subjects, 18-59 y, healthy

EXPERIMENTAL

patch test with investigation product

Other: Health care product

Interventions

Health care productOTHER

Health care product (gel) - to be applied on the participant's skin

subjects, 18-59 y, healthy

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Agreement to comply with safety guidelines to minimize contamination risks to COVID-19;
  • Agreement to perform a molecular test to detect COVID-19 to enter the study;
  • Healthy participants;
  • Non-injured skin in the test region;
  • Agreement to adhere to the test procedures and requirements and to attend the institute on the day(s) and at the time(s) determined for the evaluations;
  • ability to consent to participation in the study;
  • Age from 18 to 59 years;
  • Phototype (Fitzpatrick): I to IV;
  • All sex.

You may not qualify if:

  • Participants who belong to the risk group for COVID-19, that is, with diabetes, with chronic cardiovascular, renal and respiratory problems, immunosuppressed or other conditions that the doctor deems to belong to the risk group;
  • Pregnant or breastfeeding women;
  • Skin marks in the experimental area that interfere with the evaluation of possible skin reactions;
  • Active dermatoses;
  • Background of allergic reactions, irritation or intense discomfort sensations to topical use products;
  • History of atopy (atopic dermatitis, allergic rhinitis, allergic bronchitis, allergic conjunctivitis, etc.);
  • Sensation of discomfort with temperature changes (too hot/very cold) and/or when in the air conditioning;
  • Participants with a history of allergy to materials used in the study;
  • History of pathologies aggravated or triggered by ultraviolet radiation;
  • Carriers of immunodeficiencies;
  • Intense sun exposure or tanning session up to 15 days before the initial evaluation;
  • Prediction of intense sun exposure or tanning session during the course of the study;
  • Expected to bathe in the sea, pool or bathtub during the conduct of the study;
  • Participants who practice water sports;
  • Dermography;
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allergisa Pesquisa Dermato-Cosmética Ltda

Campinas, São Paulo, 13084-791, Brazil

Location

MeSH Terms

Conditions

Dermatitis, Contact

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Clinical trial, single-arm
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2020

First Posted

January 30, 2020

Study Start

March 9, 2021

Primary Completion

April 17, 2021

Study Completion

April 17, 2021

Last Updated

May 10, 2021

Record last verified: 2021-05

Locations

BR(1)