Skin IrritabilitySAF DER ASSESSNCT02441608

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

A study testing KL029 Intimate Lubricant Gel in people with Skin Irritability and Skin Sensitization, run by Kley Hertz S/A.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Skin Irritability, Skin Sensitization
What is being tested?: KL029 Intimate Lubricant Gel
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: No sites listed yet
Study dates: Jun 2015to Jul 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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;

Show all 12Show fewer

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;

About this study

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

Conditions: Skin Irritability, Skin Sensitization
Being tested: KL029 Intimate Lubricant Gel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT02441608
Study group	Role	What they receive
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. Receives: Device: KL029 Intimate Lubricant Gel

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 32 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2015Jul 2015

First posted12 May 2015 (estimated)
Study startJun 2015
Primary completionJun 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Skin IrritabilityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Not applicable
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02441608
Sponsor's protocol ID: KLEY HERTZ-002
Acronym: SAF DER ASSESS
Status last verified: Nov 2015
First submitted: 15 Apr 2015
Last updated: 10 Nov 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety Dermatological Assessment of Topical Use Product Through Dressings Predictive Studies for Evaluation of Photoirritation and Dermal Photosensitivity
ClinicalTrials.gov ID: NCT02441608
Acronym / sponsor ID: SAF DER ASSESS / KLEY HERTZ-002
Conditions: Skin Irritability, Skin Sensitization
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Kley Hertz S/AIndustry (pharma, biotech, devices)
Study start: Jun 2015
Primary completion: Jun 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 12 May 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Allocation: Not applicable
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 1

Arm	Type	Receives
Experimental group	Experimental	Device: KL029 Intimate Lubricant GelThis 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.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (12 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
KL029 Intimate Lubricant GelAll 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.	Device	Experimental group

Primary outcome

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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing KL029 Intimate Lubricant Gel in people with Skin Irritability and Skin Sensitization, run by Kley Hertz S/A.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Photoirritation as measured through the use of dressings containing tested product and placebo (time frame: 05 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02441608.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2015.