Skip to main content
OpenTrials
Completed

NCT Number: NCT02441608

Safety Dermatological Assessment of Topical Use Product Through Dressings Predictive Studies for Evaluation of Photoirritation and Dermal Photosensitivity

The purpose of this study is to prove the product tested does not cause photoirritation or photosensitization reactions when exposed to sun light.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age between 18 to 60 years old;
  • Skin types: I (light caucasian) or III (light brown);
  • Intact skin where the product will be applied;
  • Agreement to comply with the test procedures and attend the clinic in the days and fixed times for medical assessments and application and reading of dressings
  • Signature of informed consent form

Exclusion criteria

  • Pregnancy and lactation
  • Use of anti-inflammatory and immunosuppressive from 30 days up to three months prior to selection;
  • Diseases that cause immune suppression;
  • Use of photosensitizing drugs;
  • History or photodermatoses activities;
  • Personal or family history of photoinduced skin cancer;
  • Presence of precursor lesions of skin cancer, such as melanocytic nevi and actinic keratoses;
  • Intense sun exposure in the experiment area Use of new drugs and/or cosmetics during the experiment;
  • Previous participation in a study with the same product under test;
  • Relevant medical history or current evidence of alcohol or other drugs abuse;
  • Known historical or suspected intolerance to any ingredient of the product under study (product under test or comparator);
  • Sponsor's employees involved in the study, or close family member of an employee involved in the study;

Treatment and study plan

KL029 Intimate Lubricant Gel

Device

All the volunteers will receive the application of four dressings (3 placebos and 1 containing the tested product). After a certain period of time, photoirritation and photosensitization will be measured through the evaluation of tested region.

Primary outcomes

  1. Photoirritation as measured through the use of dressings containing tested product and placebo

    Time frame: 05 days

    The photoirritation will be measured with the use of four dressings that will be applied in the volunteer (3 dresssings containing different placebos and 1 containing the product). After some hours, the region is evaluated and irradiated with UVA. That procedure occurs during the period of five days.

  2. Photosensitization as measured through the use of dressings containing tested product and placebo

    Time frame: 32 days

    The photosensitization will be measured with the use of four dressings that will be applied in the volunteer (3 dresssings containing different placebos and 1 containing the product). After some hours, the region is evaluated and irradiated with UVA. That procedure occurs during the period of 32 days.

Sponsors and collaborators

Lead sponsor

Kley Hertz S/A

Industry

Registry information

Acronym: SAF DER ASSESS

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 12, 2015
Registry last updated
Nov 10, 2015

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.

Published trials that share one or more normalized conditions with this study.