Sunscreening Agents
Conditions
Brief 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).
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.
Interventions
OTHERPhysiogel Daily Defence Protective Day Cream Light
Investigator controlled, topical application to the epidermis at a dose of 2 milligrams per square centimeter (mg/cm2). Single application.
OTHERISO 24444:2010 P3 Standard Sunscreen
Investigator controlled, topical application to the epidermis at a dose of 2 mg/cm2. Single application.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The trained grader responsible for assessing Minimal Erythemal Dose of unprotected skin (MEDu) and Minimal Erythemal Dose of product treated (MEDp) at Visit 5 will be blinded to the product allocation of subjects. The trained grader responsible for assessing the provisional MEDu at Visit 3 will, necessarily, not be blinded since only one test site will be exposed to Ultraviolet (UV) radiation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 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°
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arithmetic Mean of Individual Sun Protection Factor (SPFi) Value | 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. |
Countries
Germany
Participant flow
Recruitment details
All the participants were randomized at one center in Germany.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Baseline population included safety population (N=26), safety population included all participants randomized and received any application of the study products.There were a total of 4 test sites assigned to each participant: 1) untreated skin for provisional MEDu assessment; 2) untreated skin for SPF assessment; 3) test product (Physiogel Daily Defence Protective Day Cream Light); and 4) reference product (ISO 24444:2010 P3 standard sunscreen). Test sites were delineated on the dorsum between the scapula and waist, either side of the spine. The test and reference products were applied topically to separate test sites by trained technician at a dose of 2 milligrams per square centimeter (mg/cm2) as per the randomization schedule. | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Other (Not specified) | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 45.7 Years STANDARD_DEVIATION 14.27 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 25 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 0 / 26 | 0 / 26 | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 | 0 / 26 | 0 / 26 |
Outcome results
Primary
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.
Time frame: Up to 24 hours post UV exposure
Population: Intent to treat (ITT, N= 25) all valid participants data with no major protocol deviations were included in the SPF calculations. All participants exposed to Ultra Violet (UV) radiation were included the safety population, irrelevant of whether they successfully complete the study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Test Product | Arithmetic Mean of Individual Sun Protection Factor (SPFi) Value | 19.4 Ratio (unit less) |
| Reference Product | Arithmetic Mean of Individual Sun Protection Factor (SPFi) Value | 14.0 Ratio (unit less) |
Comparison: CI % values (which is the percentage that half the 95 % CI represents of the mean values).