Sunscreening AgentsNCT03136107
Determination of the Sun Protection Factor (SPF) of a Cosmetic Daily De-fence Skin Cream
A study testing Physiogel Daily Defence Protective Day Cream Light and ISO 24444:2010 P3 Standard Sunscreen in people with Sunscreening Agents, run by GlaxoSmithKline at 1 site in Germany.
Trial summary
The purpose of this study is to determine the SPF of the test product according to the International Standards Organization (ISO) 24444:2010 methodology (In vivo determination of the SPF). 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?
- Physiogel Daily Defence Protective Day Cream Light and ISO 24444:2010 P3 Standard Sunscreen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteGermany
- Study dates
- 30 May 2017to 30 Jun 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
- Subjects with a Fitzpatrick Skin Type of I, II or III
- Subjects with an Individual typological 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
- Subjects 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
- Subjects with a history of systemic therapy with anti-inflammatory agents or analgesics (e.g. diclofenac) up to 3 days prior to screening
- Subjects with dermatological conditions
- Subjects with a history of abnormal response to the sun
Show all 27Show fewer
- Subjects who are tanned or have had sun exposure on the back area in the previous 4 weeks prior to screening
- Subjects having marks, blemishes or nevi or presenting existing sun damage in the test area
- Subjects having excessive hair, moles, tattoos, scars or other imperfections in the test area that could influence the investigation
- Subjects 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
- Subjects with a non-uniform skin colour or hyperpigmentation in the test area
- Subjects with a medical history of dysplastic nevi or melanoma
- Subjects with one of the following illnesses that might require regular systemic medication: Insulin-dependent diabetes, cancer
- Subjects with asthma, unless medicated
- Subjects with an electronic implant (e.g. pace maker, insulin pump, hearing aid) that cannot be removed during irradiation
- Acquired immune deficiency syndrome (AIDS) and infectious hepatitis, if known to the subjects
- 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
- Subjects who have used a tanning bed or other tanning treatment on the back area up to 1 month prior to screening
- Subjects accustomed to using tanning beds
- Subjects 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
- Subjects who will turn 71 years old before completing all assessment visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Sun Protection Factor of a Cosmetic Daily Defence Skin Cream
The purpose of this study is to determine the SPF of the test product according to the International Standards Organization (ISO) 24444:2010 methodology (In vivo determination of the SPF).
Read the detailed description
A single-center, randomized, evaluator blind, intra-individual comparison, no treatment and positive controlled clinical study to determine the SPF of Physiogel Daily Defence Protective Day Cream Light as per ISO 24444:2010. The provisional minimal erythemal dose of unprotected skin (MEDu) for each subject will be determined before starting the test phase. Once the provisional MEDu for a subject has been determined, the three test sites will be demarcated. The test product and positive control (P3 reference sunscreen formulation) will be applied to two of the three test sites. The other test site will remain unprotected. All three test sites will be exposed to UV radiation at the expected MED and subsequently evaluated for erythema 16-24 hours after UV exposure.
- Conditions
- Sunscreening Agents
- Being tested
- Physiogel Daily Defence Protective Day Cream Light, ISO 24444:2010 P3 Standard Sunscreen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiogel Daily Defence Protective Day Cream LightOther
Investigator controlled, topical application to the epidermis at a dose of 2 milligrams per square centimeter (mg/cm2). Single application.
ISO 24444:2010 P3 Standard SunscreenOther
Investigator controlled, topical application to the epidermis at a dose of 2 mg/cm2. Single application.
| Study group | Role | What they receive |
|---|---|---|
| Test product | Experimental | This arm will include all the test sites on the participants back where test product (Physiogel Daily Defence Protective Day Cream Light) will be applied. Receives: Other: Physiogel Daily Defence Protective Day Cream Light |
| Reference product | Active comparator | This arm will include all the test sites on the participants back where reference product (ISO 24444:2010 P3 standard sunscreen) will be applied. Receives: Other: ISO 24444:2010 P3 Standard Sunscreen |
| Negative control | No intervention | This arm will include all the test sites on the participants back which will be left unprotected. |
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) Value
Arithmetical 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). The Minimal Erythemal Dose (MED) was defined as the lowest dose of UV radiation that produced the first perceptible unambiguous erythema with defined borders appearing over most of the field of UV exposure, 16 to 24 hours after UV exposure. No inferential statistical analysis has been performed for this outcome. Test and reference products achieved a 95% CI of ±16.4% and ±16.6% of the mean SPF. These data meet the statistical criterion defined in ISO 24444:2010 as the 95% CI is within ±17% of the mean SPF.
Measured: Up to 24 hours post UV exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start30 May 2017
- Primary completion30 Jun 2017
- Study completion30 Jun 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKlineGSK Clinical Trials, Study director, GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136107
- Sponsor's protocol ID
- 207640
- Status last verified
- Jan 2019
- First submitted
- 27 Apr 2017
- Last updated
- 19 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Sun Protection Factor of a Cosmetic Daily Defence Skin Cream
- ClinicalTrials.gov ID
- NCT03136107
- Acronym / sponsor ID
- 207640
- Conditions
- Sunscreening Agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 30 May 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Posted 19 Apr 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 of the test product according to the International Standards Organization (ISO) 24444:2010 methodology (In vivo determination of the SPF).
Detailed description
A single-center, randomized, evaluator blind, intra-individual comparison, no treatment and positive controlled clinical study to determine the SPF of Physiogel Daily Defence Protective Day Cream Light as per ISO 24444:2010. The provisional minimal erythemal dose of unprotected skin (MEDu) for each subject will be determined before starting the test phase. Once the provisional MEDu for a subject has been determined, the three test sites will be demarcated. The test product and positive control (P3 reference sunscreen formulation) will be applied to two of the three test sites. The other test site will remain unprotected. All three test sites will be exposed to UV radiation at the expected MED and subsequently evaluated for erythema 16-24 hours after UV exposure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test product | Experimental | Other: Physiogel Daily Defence Protective Day Cream LightThis arm will include all the test sites on the participants back where test product (Physiogel Daily Defence Protective Day Cream Light) will be applied. |
| Reference product | Active comparator | Other: ISO 24444:2010 P3 Standard SunscreenThis arm will include all the test sites on the participants back where reference product (ISO 24444:2010 P3 standard sunscreen) will be applied. |
| Negative control | No intervention | –This arm will include all the test sites on the participants back which will be left unprotected. |
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
- Subjects with a Fitzpatrick Skin Type of I, II or III
- Subjects with an Individual typological angle (ITA°) greater than 28°
Key exclusion criteria (27 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
- Subjects 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
- Subjects with a history of systemic therapy with anti-inflammatory agents or analgesics (e.g. diclofenac) up to 3 days prior to screening
- Subjects 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 |
|---|---|---|
| Physiogel Daily Defence Protective Day Cream LightInvestigator controlled, topical application to the epidermis at a dose of 2 milligrams per square centimeter (mg/cm2). Single application. | Other | Test product |
| ISO 24444:2010 P3 Standard SunscreenInvestigator controlled, topical application to the epidermis at a dose of 2 mg/cm2. Single application. | Other | Reference product |
Primary outcome
Arithmetic Mean of Individual Sun Protection Factor (SPFi) Value
Time frame: Up to 24 hours post UV exposure
Arithmetical 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). The Minimal Erythemal Dose (MED) was defined as the lowest dose of UV radiation that produced the first perceptible unambiguous erythema with defined borders appearing over most of the field of UV exposure, 16 to 24 hours after UV exposure. No inferential statistical analysis has been performed for this outcome. Test and reference products achieved a 95% CI of ±16.4% and ±16.6% of the mean SPF. These data meet the statistical criterion defined in ISO 24444:2010 as the 95% CI is within ±17% of the mean SPF.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Sunscreening Agents
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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
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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
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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 Physiogel Daily Defence Protective Day Cream Light and ISO 24444:2010 P3 Standard Sunscreen 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 27 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 19 Apr 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 19 Apr 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) Value (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?
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 19 Apr 2019.