Sunscreening Agents
Conditions
Brief 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.
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).
Interventions
OTHERNGBUV000A, (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.
OTHERNGBUV000B, (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.
OTHERNGBUV000C, (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.
OTHERNGBUV000D, (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.
OTHERP3 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.
OTHERSunscreen formulation S2
A total of 1.3 mg/cm2 of sunscreen formulation S2 will be applied to the test plates.
OTHERGlycerin
A total of 1.3 mg/cm2 of glycerin will be applied to the test plates.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
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 * Participants with a Fitzpatrick Skin Type of I, II or III * Participants with an Individual Typology 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 * 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spectrum of Sun Protection | Up to 30 minutes post UV exposure | 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. |
Countries
Germany
Participant flow
Recruitment details
All the participants were enrolled at one center in Germany.
Pre-assignment details
Total of 9 participants were screened for the study out of which 1 participant did not meet the study criteria. Remaining 8 participants were randomized in the study.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Included all the participants who randomized to receive the study product. | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Other (did not meet study criteria) | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 46.4 Years STANDARD_DEVIATION 18.71 |
| 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 | 7 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 |
Outcome results
Primary
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.
Time frame: Up to 24 hours post UV exposure
Population: Analysis population included all randomized participants who underwent irradiation at Visit 4. Here, number analyzed signifies participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Test Product 1 | Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values | 33.1 Ratio |
| Test Product 2 | Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values | 35.2 Ratio |
| Test Product 3 | Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values | 35.2 Ratio |
| Test Product 4 | Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values | 45.2 Ratio |
| Reference Product (for SPFi Calculation) | Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values | 15.6 Ratio |
Secondary
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.
Time frame: Up to 30 minutes post UV exposure
Population: Analysis population included all randomized participants who underwent irradiation at Visit 4.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Product 1 | Spectrum of Sun Protection | 3.11 Ratio |
| Test Product 2 | Spectrum of Sun Protection | 2.98 Ratio |
| Test Product 3 | Spectrum of Sun Protection | 2.88 Ratio |
| Test Product 4 | Spectrum of Sun Protection | 2.95 Ratio |
| Reference Product (for SPFi Calculation) | Spectrum of Sun Protection | 1.13 Ratio |