Skin CareNCT02792595

In Vivo Sun Protection Factor Determination

A study testing Test Product A, Test Product B and Test Product C in people with Skin Care, run by GlaxoSmithKline at 1 site in Germany.

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 study aims to determine the Sun Protection Factor (SPF) of 8 cosmetic products in vivo on the back of human participants, according to the International Standard Sun Protection Test method by using a sun simulator. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Skin Care
What is being tested?: Test Product A, Test Product B and Test Product C
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 28 participants
Where: 1 siteGermany
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 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Understanding of the study and willingness to participate as demonstrated by voluntary written informed consent
Age between 18 to 70 years (inclusive)
Uniform skin and no erythema or dark pigmentation in the test area
Skin type I, II or III according to Fitzpatrick scale
Individual typological angle (ITA°) > 28 in the test area
Willingness to discontinue the use of detergents, cosmetic products in the treatment areas and to avoid any exposure of the test area to artificial or natural ultraviolet (UV) light throughout the study

Who cannot join

Breast feeding, pregnant women or who are intending to become pregnant over study duration
Acquired immunodeficiency syndrome (AIDS) or infectious hepatitis, insulin dependent diabetes, cancer, active skin disease at the test area, asthma or hypertension if not medicated, medical history of dysplastic nevi or melanoma, allergies to cosmetic products
Electronic implant that cannot be removed during irradiation
Sun exposition, UV therapy, artificial tanning within the last 4 weeks, or irregularly tanned skin in the test area
Application of leave-on cosmetics at the test area within the last 24 h prior to the study start
Moles, tattoos, scars, irritated skin, hair, etc. at the test area that could influence the investigation

Show all 13Show fewer

Usage of medications with known photo-toxic and/or photo-sensitizing potential within the last 14 days prior to study start and/or throughout the entire study course
Systemic therapy with immuno-suppresive drugs and/or antihistamines within last 7 days prior to study start and/or throughout the entire study course
Systemic therapy with anti-phlogistic agents or analgetics within last 3 days prior to study start and/or throughout the entire study course
Participation or in waiting period of 2 months after participation in similar cosmetic and/or pharmaceutical UV studies
Known or suspected intolerance or hypersensitivity to cosmetic products
Alcohol or other substance of abuse within the last 5 years
Employee of the sponsor or the study site or members of their immediate family

Trial locations and contacts

1 site in 1 country.

Germany1 site

GSK Investigational Site
Schenefeld, Schleswig-Holstein, 22869

Other trials in Germany

About this study

Official title: Sun Protection Factor Determination (In Vivo Determination of the Sun Protection Factor ISO 24444) (61-SPF-iM)

Conditions: Skin Care
Being tested: Negative Control, Positive Control, Test Product A, Test Product B, Test Product C

What participants receive

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

Negative ControlOther
Untreated area
Positive ControlOther
High SPF Standard P3/SPF 15
Test Product AOther
Yosemite Falls (Forte Day SPF upgrade) Variant A
Test Product BOther
Yosemite Falls (Forte Day SPF upgrade) Variant B
Test Product COther
Yosemite Falls (Forte Day SPF upgrade) Variant C
Test Product DOther
Yosemite Falls (Forte Day SPF upgrade) Variant D
Test Product EOther
Yosemite Falls (Forte Day SPF upgrade) Variant E
Test Product FOther
Yosemite Falls (Forte Day SPF upgrade) Variant F
Test Product GOther
Yosemite Falls (Forte Day SPF upgrade) Variant G
Test Product HOther
Yosemite Falls (Forte Day SPF upgrade) Variant H

Study groups in NCT02792595
Study group	Role	What they receive
Negative Control	Sham comparator	Untreated area will be irradiated using a sun simulator with UV irradiation increment of 1.25 to detect MED of the unprotected skin. Receives: Other: Negative Control
Positive Control	Active comparator	After irradiation of the test area with a sun simulator with an increment of UV radiation of 1.25, positive control will be applied. The dose of positive control will be measured in accordance to the application volume (2 milligram (mg)/centimeter (cm)^2 (± 0.05 mg/cm^2) and it will be applied using a micro litre syringe in approximately 15-30 small droplets all over the test area. Positive control will be then quickly spread by gently rubbing with a non-saturated finger cot, first with rotating followed by crosswise movements for a final uniform coating on the skin. Spreading time will be between 20 and 50 seconds (s). After waiting for 15 to 30 minutes (min), the test area will be again irradiated (increment of 1.12 or 1.25) with the sun simulator. The irradiation time will depend on the SPF of positive control, participants' skin prototype, determined MED after irradiation and actual power of sun simulator. Receives: Other: Positive Control
Test Product A	Experimental	After irradiation of the test area with a sun simulator with an increment of UV radiation of 1.25, test product will be applied. The dose of test product will be measured in accordance to the application volume (2 mg/cm^2 (± 0.05 mg/cm^2) and it will be applied using a micro litre syringe in approximately 15-30 small droplets all over the test area. Test product will be then quickly spread by gently rubbing with a non-saturated finger cot, first with rotating followed by crosswise movements for a final uniform coating on the skin. Spreading time will be between 20 and 50 s. After waiting for 15 to 30 min, the test area will be again irradiated (increment of 1.12 or 1.25) with the sun simulator. The irradiation time will depend on the expected SPF of the test product, participants' skin prototype, determined MED after irradiation and actual power of sun simulator. Receives: Other: Test Product A
Test Product B	Experimental	After irradiation of the test area with a sun simulator with an increment of UV radiation of 1.25, test product will be applied. The dose of test product will be measured in accordance to the application volume (2 mg/cm^2 (± 0.05 mg/cm^2) and it will be applied using a micro litre syringe in approximately 15-30 small droplets all over the test area. Test product will be then quickly spread by gently rubbing with a non-saturated finger cot, first with rotating followed by crosswise movements for a final uniform coating on the skin. Spreading time will be between 20 and 50 s. After waiting for 15 to 30 min, the test area will be again irradiated (increment of 1.12 or 1.25) with the sun simulator. The irradiation time will depend on the expected SPF of the test product, participants' skin prototype, determined MED after irradiation and actual power of sun simulator. Receives: Other: Test Product B
Test Product C	Experimental	After irradiation of the test area with a sun simulator with an increment of UV radiation of 1.25, test product will be applied. The dose of test product will be measured in accordance to the application volume (2 mg/cm^2 (± 0.05 mg/cm^2) and it will be applied using a micro litre syringe in approximately 15-30 small droplets all over the test area. Test product will be then quickly spread by gently rubbing with a non-saturated finger cot, first with rotating followed by crosswise movements for a final uniform coating on the skin. Spreading time will be between 20 and 50 s. After waiting for 15 to 30 min, the test area will be again irradiated (increment of 1.12 or 1.25) with the sun simulator. The irradiation time will depend on the expected SPF of the test product, participants' skin prototype, determined MED after irradiation and actual power of sun simulator. Receives: Other: Test Product C
Test Product D	Experimental	After irradiation of the test area with a sun simulator with an increment of UV radiation of 1.25, test product will be applied. The dose of test product will be measured in accordance to the application volume (2 mg/cm^2 (± 0.05 mg/cm^2) and it will be applied using a micro litre syringe in approximately 15-30 small droplets all over the test area. Test product will be then quickly spread by gently rubbing with a non-saturated finger cot, first with rotating followed by crosswise movements for a final uniform coating on the skin. Spreading time will be between 20 and 50 s. After waiting for 15 to 30 min, the test area will be again irradiated (increment of 1.12 or 1.25) with the sun simulator. The irradiation time will depend on the expected SPF of the test product, participants' skin prototype, determined MED after irradiation and actual power of sun simulator. Receives: Other: Test Product D
Test Product E	Experimental	After irradiation of the test area with a sun simulator with an increment of UV radiation of 1.25, test product will be applied. The dose of test product will be measured in accordance to the application volume (2 mg/cm^2 (± 0.05 mg/cm^2) and it will be applied using a micro litre syringe in approximately 15-30 small droplets all over the test area. Test product will be then quickly spread by gently rubbing with a non-saturated finger cot, first with rotating followed by crosswise movements for a final uniform coating on the skin. Spreading time will be between 20 and 50 s. After waiting for 15 to 30 min, the test area will be again irradiated (increment of 1.12 or 1.25) with the sun simulator. The irradiation time will depend on the expected SPF of the test product, participants' skin prototype, determined MED after irradiation and actual power of sun simulator. Receives: Other: Test Product E
Test Product F	Experimental	After irradiation of the test area with a sun simulator with an increment of UV radiation of 1.25, test product will be applied. The dose of test product will be measured in accordance to the application volume (2 mg/cm^2 (± 0.05 mg/cm^2) and it will be applied using a micro litre syringe in approximately 15-30 small droplets all over the test area. Test product will be then quickly spread by gently rubbing with a non-saturated finger cot, first with rotating followed by crosswise movements for a final uniform coating on the skin. Spreading time will be between 20 and 50 s. After waiting for 15 to 30 min, the test area will be again irradiated (increment of 1.12 or 1.25) with the sun simulator. The irradiation time will depend on the expected SPF of the test product, participants' skin prototype, determined MED after irradiation and actual power of sun simulator. Receives: Other: Test Product F
Test Product G	Experimental	After irradiation of the test area with a sun simulator with an increment of UV radiation of 1.25, test product will be applied. The dose of test product will be measured in accordance to the application volume (2 mg/cm^2 (± 0.05 mg/cm^2) and it will be applied using a micro litre syringe in approximately 15-30 small droplets all over the test area. Test product will be then quickly spread by gently rubbing with a non-saturated finger cot, first with rotating followed by crosswise movements for a final uniform coating on the skin. Spreading time will be between 20 and 50 s. After waiting for 15 to 30 min, the test area will be again irradiated (increment of 1.12 or 1.25) with the sun simulator. The irradiation time will depend on the expected SPF of the test product, participants' skin prototype, determined MED after irradiation and actual power of sun simulator. Receives: Other: Test Product G
Test Product H	Experimental	After irradiation of the test area with a sun simulator with an increment of UV radiation of 1.25, test product will be applied. The dose of test product will be measured in accordance to the application volume (2 mg/cm^2 (± 0.05 mg/cm^2) and it will be applied using a micro litre syringe in approximately 15-30 small droplets all over the test area. Test product will be then quickly spread by gently rubbing with a non-saturated finger cot, first with rotating followed by crosswise movements for a final uniform coating on the skin. Spreading time will be between 20 and 50 s. After waiting for 15 to 30 min, the test area will be again irradiated (increment of 1.12 or 1.25) with the sun simulator. The irradiation time will depend on the expected SPF of the test product, participants' skin prototype, determined MED after irradiation and actual power of sun simulator. Receives: Other: Test Product H

What is being measured

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

Visual evaluation of irradiated skin
Visual evaluation of irradiated test area will be carried out to determine Minimal Erthemal Dose (MED). The lowest irradiation dose producing perceptible erythema will be chosen as MED. The individual SPF (SPFi) for each test product will be determined by calculating the ratio of the MED on test product protected skin (MEDp) to the MED on unprotected skin (MEDu).
Measured: Upto 2 weeks

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 posted7 Jun 2016 (estimated)
Study startJun 2015
Primary completionJul 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 CareStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
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
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02792595
Sponsor's protocol ID: 204736
Status last verified: Jun 2016
First submitted: 25 Jun 2015
Last updated: 20 Jun 2016
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?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sun Protection Factor Determination (In Vivo Determination of the Sun Protection Factor ISO 24444) (61-SPF-iM)
ClinicalTrials.gov ID: NCT02792595
Acronym / sponsor ID: 204736
Conditions: Skin Care
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Jun 2015
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 7 Jun 2016 (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.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: Double blind (participant, outcomes assessor)
Number of arms: 10

Arm	Type	Receives
Negative Control	Sham comparator	Other: Negative ControlUntreated area will be irradiated using a sun simulator with UV irradiation increment of 1.25 to detect MED of the unprotected skin.
Positive Control	Active comparator	Other: Positive ControlAfter irradiation of the test area with a sun simulator with an increment of UV radiation of 1.25, positive control will be applied. The dose of positive control will be measured in accordance to the application volume (2 milligram (mg)/centimeter (cm)^2 (± 0.05 mg/cm^2) and it will be applied using a micro litre syringe in approximately 15-30 small droplets all over the test area. Positive control will be then quickly spread by gently rubbing with a non-saturated finger cot, first with rotating followed by crosswise movements for a final uniform coating on the skin. Spreading time will be between 20 and 50 seconds (s). After waiting for 15 to 30 minutes (min), the test area will be again irradiated (increment of 1.12 or 1.25) with the sun simulator. The irradiation time will depend on the SPF of positive control, participants' skin prototype, determined MED after irradiation and actual power of sun simulator.
Test Product A	Experimental	Other: Test Product AAfter irradiation of the test area with a sun simulator with an increment of UV radiation of 1.25, test product will be applied. The dose of test product will be measured in accordance to the application volume (2 mg/cm^2 (± 0.05 mg/cm^2) and it will be applied using a micro litre syringe in approximately 15-30 small droplets all over the test area. Test product will be then quickly spread by gently rubbing with a non-saturated finger cot, first with rotating followed by crosswise movements for a final uniform coating on the skin. Spreading time will be between 20 and 50 s. After waiting for 15 to 30 min, the test area will be again irradiated (increment of 1.12 or 1.25) with the sun simulator. The irradiation time will depend on the expected SPF of the test product, participants' skin prototype, determined MED after irradiation and actual power of sun simulator.
Test Product B	Experimental	Other: Test Product BAfter irradiation of the test area with a sun simulator with an increment of UV radiation of 1.25, test product will be applied. The dose of test product will be measured in accordance to the application volume (2 mg/cm^2 (± 0.05 mg/cm^2) and it will be applied using a micro litre syringe in approximately 15-30 small droplets all over the test area. Test product will be then quickly spread by gently rubbing with a non-saturated finger cot, first with rotating followed by crosswise movements for a final uniform coating on the skin. Spreading time will be between 20 and 50 s. After waiting for 15 to 30 min, the test area will be again irradiated (increment of 1.12 or 1.25) with the sun simulator. The irradiation time will depend on the expected SPF of the test product, participants' skin prototype, determined MED after irradiation and actual power of sun simulator.
Test Product C	Experimental	Other: Test Product CAfter irradiation of the test area with a sun simulator with an increment of UV radiation of 1.25, test product will be applied. The dose of test product will be measured in accordance to the application volume (2 mg/cm^2 (± 0.05 mg/cm^2) and it will be applied using a micro litre syringe in approximately 15-30 small droplets all over the test area. Test product will be then quickly spread by gently rubbing with a non-saturated finger cot, first with rotating followed by crosswise movements for a final uniform coating on the skin. Spreading time will be between 20 and 50 s. After waiting for 15 to 30 min, the test area will be again irradiated (increment of 1.12 or 1.25) with the sun simulator. The irradiation time will depend on the expected SPF of the test product, participants' skin prototype, determined MED after irradiation and actual power of sun simulator.
Test Product D	Experimental	Other: Test Product DAfter irradiation of the test area with a sun simulator with an increment of UV radiation of 1.25, test product will be applied. The dose of test product will be measured in accordance to the application volume (2 mg/cm^2 (± 0.05 mg/cm^2) and it will be applied using a micro litre syringe in approximately 15-30 small droplets all over the test area. Test product will be then quickly spread by gently rubbing with a non-saturated finger cot, first with rotating followed by crosswise movements for a final uniform coating on the skin. Spreading time will be between 20 and 50 s. After waiting for 15 to 30 min, the test area will be again irradiated (increment of 1.12 or 1.25) with the sun simulator. The irradiation time will depend on the expected SPF of the test product, participants' skin prototype, determined MED after irradiation and actual power of sun simulator.
Test Product E	Experimental	Other: Test Product EAfter irradiation of the test area with a sun simulator with an increment of UV radiation of 1.25, test product will be applied. The dose of test product will be measured in accordance to the application volume (2 mg/cm^2 (± 0.05 mg/cm^2) and it will be applied using a micro litre syringe in approximately 15-30 small droplets all over the test area. Test product will be then quickly spread by gently rubbing with a non-saturated finger cot, first with rotating followed by crosswise movements for a final uniform coating on the skin. Spreading time will be between 20 and 50 s. After waiting for 15 to 30 min, the test area will be again irradiated (increment of 1.12 or 1.25) with the sun simulator. The irradiation time will depend on the expected SPF of the test product, participants' skin prototype, determined MED after irradiation and actual power of sun simulator.
Test Product F	Experimental	Other: Test Product FAfter irradiation of the test area with a sun simulator with an increment of UV radiation of 1.25, test product will be applied. The dose of test product will be measured in accordance to the application volume (2 mg/cm^2 (± 0.05 mg/cm^2) and it will be applied using a micro litre syringe in approximately 15-30 small droplets all over the test area. Test product will be then quickly spread by gently rubbing with a non-saturated finger cot, first with rotating followed by crosswise movements for a final uniform coating on the skin. Spreading time will be between 20 and 50 s. After waiting for 15 to 30 min, the test area will be again irradiated (increment of 1.12 or 1.25) with the sun simulator. The irradiation time will depend on the expected SPF of the test product, participants' skin prototype, determined MED after irradiation and actual power of sun simulator.
Test Product G	Experimental	Other: Test Product GAfter irradiation of the test area with a sun simulator with an increment of UV radiation of 1.25, test product will be applied. The dose of test product will be measured in accordance to the application volume (2 mg/cm^2 (± 0.05 mg/cm^2) and it will be applied using a micro litre syringe in approximately 15-30 small droplets all over the test area. Test product will be then quickly spread by gently rubbing with a non-saturated finger cot, first with rotating followed by crosswise movements for a final uniform coating on the skin. Spreading time will be between 20 and 50 s. After waiting for 15 to 30 min, the test area will be again irradiated (increment of 1.12 or 1.25) with the sun simulator. The irradiation time will depend on the expected SPF of the test product, participants' skin prototype, determined MED after irradiation and actual power of sun simulator.
Test Product H	Experimental	Other: Test Product HAfter irradiation of the test area with a sun simulator with an increment of UV radiation of 1.25, test product will be applied. The dose of test product will be measured in accordance to the application volume (2 mg/cm^2 (± 0.05 mg/cm^2) and it will be applied using a micro litre syringe in approximately 15-30 small droplets all over the test area. Test product will be then quickly spread by gently rubbing with a non-saturated finger cot, first with rotating followed by crosswise movements for a final uniform coating on the skin. Spreading time will be between 20 and 50 s. After waiting for 15 to 30 min, the test area will be again irradiated (increment of 1.12 or 1.25) with the sun simulator. The irradiation time will depend on the expected SPF of the test product, participants' skin prototype, determined MED after irradiation and actual power of sun simulator.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Understanding of the study and willingness to participate as demonstrated by voluntary written informed consent
Age between 18 to 70 years (inclusive)
Uniform skin and no erythema or dark pigmentation in the test area
Skin type I, II or III according to Fitzpatrick scale
Individual typological angle (ITA°) > 28 in the test area

Key exclusion criteria (13 listed)

Breast feeding, pregnant women or who are intending to become pregnant over study duration
Acquired immunodeficiency syndrome (AIDS) or infectious hepatitis, insulin dependent diabetes, cancer, active skin disease at the test area, asthma or hypertension if not medicated, medical history of dysplastic nevi or melanoma, allergies to cosmetic products
Electronic implant that cannot be removed during irradiation
Sun exposition, UV therapy, artificial tanning within the last 4 weeks, or irregularly tanned skin in the test area
Application of leave-on cosmetics at the test area within the last 24 h prior to the study start

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
Negative ControlUntreated area	Other	Negative Control
Positive ControlHigh SPF Standard P3/SPF 15	Other	Positive Control
Test Product AYosemite Falls (Forte Day SPF upgrade) Variant A	Other	Test Product A
Test Product BYosemite Falls (Forte Day SPF upgrade) Variant B	Other	Test Product B
Test Product CYosemite Falls (Forte Day SPF upgrade) Variant C	Other	Test Product C
Test Product DYosemite Falls (Forte Day SPF upgrade) Variant D	Other	Test Product D
Test Product EYosemite Falls (Forte Day SPF upgrade) Variant E	Other	Test Product E
Test Product FYosemite Falls (Forte Day SPF upgrade) Variant F	Other	Test Product F
Test Product GYosemite Falls (Forte Day SPF upgrade) Variant G	Other	Test Product G
Test Product HYosemite Falls (Forte Day SPF upgrade) Variant H	Other	Test Product H

Primary outcome

Visual evaluation of irradiated skin
Time frame: Upto 2 weeks
Visual evaluation of irradiated test area will be carried out to determine Minimal Erthemal Dose (MED). The lowest irradiation dose producing perceptible erythema will be chosen as MED. The individual SPF (SPFi) for each test product will be determined by calculating the ratio of the MED on test product protected skin (MEDp) to the MED on unprotected skin (MEDu).

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 20 Jun 2016.

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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.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Test Product A, Test Product B and Test Product C in people with Skin Care, run by GlaxoSmithKline at 1 site in Germany.

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 6 inclusion and 13 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 20 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Visual evaluation of irradiated skin (time frame: Upto 2 weeks). 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 NCT02792595.

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 20 Jun 2016.