Trials Sponsors Conditions Drugs Pricing

Conditions

Skin Irritability Skin Sensitization

Outcome Measures

Primary Outcomes (2)

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.
05 days
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.
32 days

Study Arms (1)

Experimental group

EXPERIMENTAL

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

KL029 Intimate Lubricant GelDevice

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.

Experimental group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 60 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Age between 18 to 60 years old;
Skin types: I (light caucasian) or III (light brown);

Sponsors & Collaborators

Kley Hertz S/A
Industrylead

Enrollment

28 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: SINGLE
Who Masked: PARTICIPANT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 15, 2015

First Posted

May 12, 2015

Study Start

June 2015

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Experimental group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Experimental group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record