Sunscreening AgentsNCT03157583

A Study to Measure the Sun Protection Factor (SPF) and Ultraviolet-A Protection Factor (UVAPF) of Four Developmental Sunscreen Formulations

A study testing NGBUV000A, (Expected SPF 30), NGBUV000B, (Expected SPF 30) and NGBUV000C, (Expected SPF 30) in people with Sunscreening Agents, 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 purpose of this study is to determine the SPF and UVAPF of four sunscreen formulations using international standard methodologies ISO24444:2010 for SPF and ISO24443:2012 for UVAPF. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Sunscreening Agents
What is being tested?: NGBUV000A, (Expected SPF 30), NGBUV000B, (Expected SPF 30) and NGBUV000C, (Expected SPF 30)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteGermany
Study dates: 21 Jun 2017to 7 Jul 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination
Participants with a Fitzpatrick Skin Type of I, II or III
Participants with an Individual Typology Angle (ITA°) greater than 28°

Who cannot join

Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
Women who are breast-feeding or lactating
Participants having used medication with known photo-toxic and/or photosensitizing potential (e.g. hypericum perforatum, antibiotics, blood pressure regulating agents) up to 14 days prior to screening
Participants with a history of systemic therapy with anti-inflammatory agents or analgesics (e.g. diclofenac) up to 3 days prior to screening
Participants with dermatological conditions
Participants with a history of abnormal response to the sun

Show all 25Show fewer

Participants having marks, blemishes or nevi or presenting existing sun damage in the test area
Participants having excessive hair, moles, tattoos, scars or other imperfections in the test area that could influence the investigation
Participants with a history of systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. anti-allergics) up to 7 days prior to screening
Participants with a non-uniform skin colour or hyperpigmentation in the test area
Participants with a medical history of dysplastic nevi or melanoma
Participants with one of the following illnesses that might require regular systemic medication: Insulin-dependent diabetes, cancer
Participants with asthma, unless medicated
Participants with an electronic implant (e.g. pace maker, insulin pump, hearing aid) that cannot be removed during irradiation
AIDS (acquired immune deficiency syndrome) and infectious hepatitis, if known to the participants
Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
Known allergy to latex
Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days prior to screening
Participation in another clinical study involving UV exposure to the same test site up to 2 months prior to screening
Previous participation in this study
Recent history (within the last 5 years) of alcohol or other substance abuse
Participants who have used a tanning bed or other tanning treatment on the back area up to 1 month prior to screening
Participants accustomed to using tanning beds
Participants who have used self-tanning products on the back area in the previous 1 month prior to screening
An 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: Determination of the Sun Protection Factor (SPF) and in Vitro UVA Protection Factor (UVAPF) of Four Developmental Sunscreen Formulations

The purpose of this study is to determine the SPF and UVAPF of four sunscreen formulations using international standard methodologies ISO24444:2010 for SPF and ISO24443:2012 for UVAPF.

Read the detailed description

This study consist of two steps. Step 1: determination of the SPF of the test products which will be performed as a single-center, randomized, evaluator blind, intra-individual comparison, no treatment and positive controlled clinical study as per ISO24444:2010. And Step 2: determination of the UVAPF of the test products which will be performed as a single center, open-label, negative and positive controlled technical test as per ISO24443:2012 (using test plates for assessing UV transmittance of four developmental sunscreens).

Conditions: Sunscreening Agents
Being tested: NGBUV000A, (Expected SPF 30), NGBUV000B, (Expected SPF 30), NGBUV000C, (Expected SPF 30), NGBUV000D, (Expected SPF 30), P3 Standard, (Expected SPF 16)

What participants receive

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

NGBUV000A, (Expected SPF 30)Other
A total of 2.0 ± 0.05 mg/cm2 (milligram per centimeter square of test site area) NGBUV000A (test product 1) will be spread at the topical test sites on the back of each participant. And a total of 1.3 mg/cm2 of test product 1 will be applied to the test plates.
NGBUV000B, (Expected SPF 30)Other
A total of 2.0 ± 0.05 mg/cm2 NGBUV000B (test product 2) will be spread at the topical test sites on the back of each participant. And a total of 1.3 mg/cm2 of test product 2 will be applied to the test plates.
NGBUV000C, (Expected SPF 30)Other
A total of 2.0 ± 0.05 mg/cm2 NGBUV000C (test product 3) will be spread at the topical test sites on the back of each participant. And a total of 1.3 mg/cm2 of test product 3 will be applied to the test plates.
NGBUV000D, (Expected SPF 30)Other
A total of 2.0 ± 0.05 mg/cm2 NGBUV000D (test product 4) will be spread at the topical test sites on the back of each participant. And a total of 1.3 mg/cm2 of test product 4 will be applied to the test plates.
P3 Standard, (Expected SPF 16)Other
A total of 2.0 ± 0.05 mg/cm2 reference P3 standard will be spread at the topical test sites on the back of each participant.
Sunscreen formulation S2Other
A total of 1.3 mg/cm2 of sunscreen formulation S2 will be applied to the test plates.
GlycerinOther
A total of 1.3 mg/cm2 of glycerin will be applied to the test plates.

Study groups in NCT03157583
Study group	Role	What they receive
Reference product (for SPFi calculation)	Active comparator	This arm will include all the test sites on the participants back where reference product (P3 standard sunscreen) will be applied. Receives: Other: P3 Standard, (Expected SPF 16)
Test product 1	Experimental	This arm will include all the test plates used for UVAPF testing and test sites on the participants back where test product 1 will be applied for SPF testing. Receives: Other: NGBUV000A, (Expected SPF 30)
Test product 2	Experimental	This arm will include all the test plates used for UVAPF testing and test sites on the participants back where test product 2 will be applied for SPF testing. Receives: Other: NGBUV000B, (Expected SPF 30)
Test product 3	Experimental	This arm will include all the test plates used for UVAPF testing and test sites on the participants back where test product 3 will be applied for SPF testing. Receives: Other: NGBUV000C, (Expected SPF 30)
Test product 4	Experimental	This arm will include all the test plates used for UVAPF testing and test sites on the participants back where test product 4 will be applied for SPF testing. Receives: Other: NGBUV000D, (Expected SPF 30)
Negative control (for SPFi calculation)	No intervention	This arm will include all the test sites on the participants back which will be left unprotected.
Reference (for UVAPFi calculation)	Active comparator	This arm will include test plates treated with reference sunscreen formulation S2. Receives: Other: Sunscreen formulation S2
Blank control (for UVAPFi calculation)	Other	This arm will include blank test plates treated with glycerin. Receives: Other: Glycerin

What is being measured

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

Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values
Arithmetic mean of all valid SPFi values of each product on each participant was calculated from the individual Minimal Erythemal Dose (MED) on product treated (MEDp) test sites in relation to unprotected (MEDu) test sites 16-24 hours after exposure to ultraviolet (UV) radiation. SPFi = MEDp/MEDu. No inferential statistical analysis was performed for this outcome.The provisional MEDu was the lowest dose of UV radiation that produces the first perceptible unambiguous erythema with defined borders appearing over most of the field of UV exposure.Higher values represents increased SPF protection.
Measured: Up to 24 hours post UV exposure

Secondary outcomes (1)

Spectrum of Sun Protection
Broad spectrum of sun protection was calculated by the ratio of the arithmetic mean of SPF to the arithmetic mean of UVAPF. Higher values represents increased SPF protection.
Measured: Up to 30 minutes post UV exposure

Timeline

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

21 Jun 20177 Jul 2017

First posted17 May 2017
Study start21 Jun 2017
Primary completion7 Jul 2017
Study completion7 Jul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Sunscreening AgentsStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03157583
Sponsor's protocol ID: 207583
Status last verified: May 2019
First submitted: 16 May 2017
Last updated: 22 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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?

See locations

Active, not recruiting
Sun Exposure and Activities After Skin Cancer: Optimization of mHealth Interventions
Melanoma (Skin Cancer)
RecruitingPhase 4
A Clinical Study to Evaluate the Efficacy and SPF of Two Test Materials According to an Adaptation of the Guidelines of the FDA Sunscreen Drug Products for Over-the-Counter Human Use
Epidermis, Ultraviolet Exposure
Recruiting
A Clinical Study to Evaluate the Efficacy in Improving Dark Spots After 8 Weeks of Use of Facial Sunscreens in Adult Participants
Post-inflammatory Hyperpigmentation, Melasma
Enrolling by invitationObservational study
Expert Consensus on Photoprotection Practices: A Delphi Study
Photoprotection, Sunscreen
Enrolling by invitation
Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics
Sunburn, Sun Damaged Skin

All Sunscreening Agents trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Determination of the Sun Protection Factor (SPF) and in Vitro UVA Protection Factor (UVAPF) of Four Developmental Sunscreen Formulations
ClinicalTrials.gov ID: NCT03157583
Acronym / sponsor ID: 207583
Conditions: Sunscreening Agents
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 21 Jun 2017 (actual)
Primary completion: 7 Jul 2017 (actual)
Study completion: 7 Jul 2017 (actual)
First posted: 17 May 2017 (actual)
Results: Posted 22 Jul 2019

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 determine the SPF and UVAPF of four sunscreen formulations using international standard methodologies ISO24444:2010 for SPF and ISO24443:2012 for UVAPF.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 8

Arm	Type	Receives
Reference product (for SPFi calculation)	Active comparator	Other: P3 Standard, (Expected SPF 16)This arm will include all the test sites on the participants back where reference product (P3 standard sunscreen) will be applied.
Test product 1	Experimental	Other: NGBUV000A, (Expected SPF 30)This arm will include all the test plates used for UVAPF testing and test sites on the participants back where test product 1 will be applied for SPF testing.
Test product 2	Experimental	Other: NGBUV000B, (Expected SPF 30)This arm will include all the test plates used for UVAPF testing and test sites on the participants back where test product 2 will be applied for SPF testing.
Test product 3	Experimental	Other: NGBUV000C, (Expected SPF 30)This arm will include all the test plates used for UVAPF testing and test sites on the participants back where test product 3 will be applied for SPF testing.
Test product 4	Experimental	Other: NGBUV000D, (Expected SPF 30)This arm will include all the test plates used for UVAPF testing and test sites on the participants back where test product 4 will be applied for SPF testing.
Negative control (for SPFi calculation)	No intervention	–This arm will include all the test sites on the participants back which will be left unprotected.
Reference (for UVAPFi calculation)	Active comparator	Other: Sunscreen formulation S2This arm will include test plates treated with reference sunscreen formulation S2.
Blank control (for UVAPFi calculation)	Other	Other: GlycerinThis arm will include blank test plates treated with glycerin.

Who may qualify

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

Key inclusion criteria (4 listed)

Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination
Participants with a Fitzpatrick Skin Type of I, II or III
Participants with an Individual Typology Angle (ITA°) greater than 28°

Key exclusion criteria (25 listed)

Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
Women who are breast-feeding or lactating
Participants having used medication with known photo-toxic and/or photosensitizing potential (e.g. hypericum perforatum, antibiotics, blood pressure regulating agents) up to 14 days prior to screening
Participants with a history of systemic therapy with anti-inflammatory agents or analgesics (e.g. diclofenac) up to 3 days prior to screening
Participants with dermatological conditions

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
NGBUV000A, (Expected SPF 30)A total of 2.0 ± 0.05 mg/cm2 (milligram per centimeter square of test site area) NGBUV000A (test product 1) will be spread at the topical test sites on the back of each participant. And a total of 1.3 mg/cm2 of test product 1 will be applied to the test plates.	Other	Test product 1
NGBUV000B, (Expected SPF 30)A total of 2.0 ± 0.05 mg/cm2 NGBUV000B (test product 2) will be spread at the topical test sites on the back of each participant. And a total of 1.3 mg/cm2 of test product 2 will be applied to the test plates.	Other	Test product 2
NGBUV000C, (Expected SPF 30)A total of 2.0 ± 0.05 mg/cm2 NGBUV000C (test product 3) will be spread at the topical test sites on the back of each participant. And a total of 1.3 mg/cm2 of test product 3 will be applied to the test plates.	Other	Test product 3
NGBUV000D, (Expected SPF 30)A total of 2.0 ± 0.05 mg/cm2 NGBUV000D (test product 4) will be spread at the topical test sites on the back of each participant. And a total of 1.3 mg/cm2 of test product 4 will be applied to the test plates.	Other	Test product 4
P3 Standard, (Expected SPF 16)A total of 2.0 ± 0.05 mg/cm2 reference P3 standard will be spread at the topical test sites on the back of each participant.	Other	Reference product (for SPFi calculation)
Sunscreen formulation S2A total of 1.3 mg/cm2 of sunscreen formulation S2 will be applied to the test plates.	Other	Reference (for UVAPFi calculation)
GlycerinA total of 1.3 mg/cm2 of glycerin will be applied to the test plates.	Other	Blank control (for UVAPFi calculation)

Primary outcome

Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values
Time frame: Up to 24 hours post UV exposure
Arithmetic mean of all valid SPFi values of each product on each participant was calculated from the individual Minimal Erythemal Dose (MED) on product treated (MEDp) test sites in relation to unprotected (MEDu) test sites 16-24 hours after exposure to ultraviolet (UV) radiation. SPFi = MEDp/MEDu. No inferential statistical analysis was performed for this outcome.The provisional MEDu was the lowest dose of UV radiation that produces the first perceptible unambiguous erythema with defined borders appearing over most of the field of UV exposure.Higher values represents increased SPF protection.

1 secondary outcome

Spectrum of Sun Protection
Time frame: Up to 30 minutes post UV exposure

Results and safety

Results posted to the registry on 22 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	8	7

Primary outcome: Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values

Time frame: Up to 24 hours post UV exposure. Mean (95% Confidence Interval). Unit: Ratio

Measure	Test Product 1 n = 7	Test Product 2 n = 7	Test Product 3 n = 7	Test Product 4 n = 7	Reference Product (for SPFi Calculation) n = 7
Value	33.1 (26.08 to 40.22)	35.2 (25.85 to 44.42)	35.2 (26.82 to 43.68)	45.2 (38.80 to 51.58)	15.6 (12.66 to 18.59)

Population analysed: Analysis population included all randomized participants who underwent irradiation at Visit 4. Here, number analyzed signifies participants with available data for this outcome measure.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Approximately 16 days. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Reference Product (for SPFi Calculation)	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Negative Control (for SPFi Calculation)	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Test Product 1	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Test Product 2	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Test Product 3	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Test Product 4	0 of 8 (0%)	0 of 8 (0%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Sunscreening Agents

Active, not recruiting
Sun Exposure and Activities After Skin Cancer: Optimization of mHealth Interventions
Melanoma (Skin Cancer)
RecruitingPhase 4
A Clinical Study to Evaluate the Efficacy and SPF of Two Test Materials According to an Adaptation of the Guidelines of the FDA Sunscreen Drug Products for Over-the-Counter Human Use
Epidermis, Ultraviolet Exposure
Recruiting
A Clinical Study to Evaluate the Efficacy in Improving Dark Spots After 8 Weeks of Use of Facial Sunscreens in Adult Participants
Post-inflammatory Hyperpigmentation, Melasma
Enrolling by invitationObservational study
Expert Consensus on Photoprotection Practices: A Delphi Study
Photoprotection, Sunscreen
Enrolling by invitation
Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics
Sunburn, Sun Damaged Skin

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

GSK Clinical Trials study director

GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

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

Questions about this trial

What is this clinical trial studying?

A study testing NGBUV000A, (Expected SPF 30), NGBUV000B, (Expected SPF 30) and NGBUV000C, (Expected SPF 30) in people with Sunscreening Agents, 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 4 inclusion and 25 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 22 Jul 2019. 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. 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?

Yes. Results are posted in the registry (first posted 22 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values (time frame: Up to 24 hours post UV exposure). 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 NCT03157583.

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 22 Jul 2019.