Trial Outcomes & Findings for A Study to Measure the Sun Protection Factor (SPF) and Ultraviolet-A Protection Factor (UVAPF) of Four Developmental Sunscreen Formulations (NCT NCT03157583)

Last Updated: 2019-07-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

8 participants

Primary outcome timeframe

Up to 24 hours post UV exposure

Results posted on

2019-07-22

Participant Flow

All the participants were enrolled at one center in Germany.

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.

Participant milestones

Participant milestones
Measure	All Participants All the participants randomized to the study. In this study, there were a total of 7 test sites assigned to each participant. One test site was used for provisional MEDu (Minimal Erythemal Dose of Unprotected Skin) measurement, on the remaining 6 sites test products (4) and the positive control product (P3 standard) were applied and 1 site was left unprotected.
Overall Study STARTED	8
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants All the participants randomized to the study. In this study, there were a total of 7 test sites assigned to each participant. One test site was used for provisional MEDu (Minimal Erythemal Dose of Unprotected Skin) measurement, on the remaining 6 sites test products (4) and the positive control product (P3 standard) were applied and 1 site was left unprotected.
Overall Study Other (did not meet study criteria)	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=8 Participants Included all the participants who randomized to receive the study product.
Age, Continuous	46.4 Years STANDARD_DEVIATION 18.71 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Test Product 1 n=7 Participants This arm included all the test sites on the participants back where test product 1 was applied for SPF testing.	Test Product 2 n=7 Participants This arm included all the test sites on the participants back where test product 2 was applied for SPF testing.	Test Product 3 n=7 Participants This arm included all the test sites on the participants back where test product 3 was applied for SPF testing.	Test Product 4 n=7 Participants This arm included all the test sites on the participants back where test product 4 was applied for SPF testing.	Reference Product (for SPFi Calculation) n=7 Participants This arm included all the test sites on the participants back where reference product (P3 standard sunscreen) was applied.
Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values	33.1 Ratio Interval 26.08 to 40.22	35.2 Ratio Interval 25.85 to 44.42	35.2 Ratio Interval 26.82 to 43.68	45.2 Ratio Interval 38.8 to 51.58	15.6 Ratio Interval 12.66 to 18.59

SECONDARY outcome

Timeframe: Up to 30 minutes post UV exposure

Population: Analysis population included all randomized participants who underwent irradiation at Visit 4.

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.