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CompletedNCT02441608SAF DER ASSESSUpdated Nov 10, 2015

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

An interventional study of KL029 Intimate Lubricant Gel in Skin Irritability and Skin Sensitization, sponsored by Kley Hertz S/A. Completed. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-10.

Sponsored by Kley Hertz S/A · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Skin Irritability
  • Skin Sensitization
03

In context

Lead sponsor

Kley Hertz S/A is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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;
05

Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Participant)
Enrollment
28 participants (actual)

Study arms

  • 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: KL029 Intimate Lubricant Gel

Interventions

  • DeviceKL029 Intimate Lubricant 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.

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: 05 days

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

    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.

    Time frame: 32 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02441608
Lead sponsor
Kley Hertz S/A
Responsible party
Sponsor
First posted
May 12, 2015
Start date
Jun 2015
Primary completion
Jun 2015
Completion
Jul 2015
Last update
Nov 10, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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