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Completed

NCT Number: NCT04332445

Dermatological Assessment of Primary Dermal Irritability Accumulated, Sensitization, Photoallergy and Phototoxicity.

This is a clinical study for health care product safety assessment. The research is going to conducted with 55 subjects, aged 18 to 70 years. The product is applied on the right and/or left participant back. After a wash out, the product is reapplied. Medical evaluation will be available throughout the study to assess possible adverse events. The main 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, photoallergy and phototoxicity.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kosmoscience Ciência e Tecnologia Cosmética Ltda

Campinas, São Paulo, 13041-315, Brazil

About this study

Subjects phototypes I to IV (according to Fitzpatrick classification). The products is applied over semi-occlusive dressings, remaing in contact with the skin.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • Phototype (Fitzpatrick): II and III;

Exclusion criteria

  • Pregnant or breastfeeding women;
  • Use of the following systemic drugs: antihistamines, non-hormonal anti-inflammatory drugs and corticoids;
  • History of allergy to cosmetics, topical products or research product;
  • Localized or widespread dermatological diseases or inflammatory dermatoses active and nerve damage in the test region;
  • Personal or family pathological history of skin cancer;
  • Use of topical or systemic photosensitizing medication;
  • History of phototoxic, photoallergic reactions, dermatoses caused by light, atopy, pathologies aggravated or triggered by ultraviolet radiation;
  • Photo-induced pathologies;
  • Frequent exposure to the sun or tanning chambers;
  • Participated in an allergenicity study in a period of less than 4 weeks from the start of the study;
  • Skin marks in the experimental area that interfere with the evaluation of possible reactions;
  • Active dermatoses;
  • Forecast to take a bath in the sea, pool or sauna during the study;
  • Participants who play water sports;
  • Dermography;
  • Use of the following topical or systemic drugs: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs and corticoids up to 2 weeks prior to selection or, considering deposit corticoids, the interval shall be 1 month prior to selection;
  • Treatment with acid vitamin A and/or its derivatives via oral or topical until

1 month before the beginning of the study;

  • Aesthetic and/or body dermatological treatment until 3 weeks before selection;
  • Vaccination during the study or until 3 weeks before the study;
  • Being participated in another clinical trial.

Treatment and study plan

Hyaluronic Acid Gel

Other

Health care product - to be apllied on the subject's skin

Primary outcomes

  1. Erythema degree or absence

    Time frame: 39 days

    Erythema evaluation according to International Contact Dermatitis Research Group

Sponsors and collaborators

Lead sponsor

Herbarium Laboratorio Botanico Ltda

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 2, 2020
Registry last updated
Nov 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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