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Safety Dermatological Assessment of Topical Use Product Through Dressings Predictive Studies for Evaluation of Photoirritation and Dermal Photosensitivity (SAF DER ASSESS)

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ClinicalTrials.gov Identifier: NCT03015103
Recruitment Status : Unknown
Verified December 2016 by Kley Hertz S/A.
Recruitment status was:  Not yet recruiting
First Posted : January 9, 2017
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
Kley Hertz S/A

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

Condition or disease Intervention/treatment Phase
Skin Irritability Skin Sensitisation Device: Intimate Lubrificant Gel Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Official Title: Safety Dermatological Assessment of Topical Use Product Through Dressings Predictive Studies for Evaluation of Photoirritation and Dermal Photosensitivity
Study Start Date : January 2017
Estimated Primary Completion Date : February 2017

Arm Intervention/treatment
Experimental: Experimental group
This study is designed as a single group assignment, because the 4 dressings (3 placebos and 1 containing the product) will be applied in all volunteers. This means that the region in which the tested product will be applied will be compared with the other placebo regions in the same volunteer.
Device: Intimate Lubrificant Gel
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 Outcome Measures :
  1. Photoirritation as measured through the use of dressings containing tested product and placebo [ Time Frame: 5 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 radiated 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 radiated with UVA. That procedure occurs during the period of 32 days.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age between 18 to 70 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;
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Responsible Party: Kley Hertz S/A
ClinicalTrials.gov Identifier: NCT03015103    
Other Study ID Numbers: Kley Hertz 006
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: December 2016