Erythema Clinical Trial
Official title:
A Single Center, Randomized, Split Body and Split Face, Double-Blinded, Multiple Sun Exposure Evaluation of Sunscreens of SPF 50+ and Above Under Actual Use Conditions
This is a randomized, double-blinded, single-center, split body and split face, multiple natural sunlight exposure evaluation of two marketed sunscreens under actual use conditions in healthy volunteers. Eligible subjects will be randomized to two treatment randomization groups: Left SPF (Sun Protection Factor) 100+/Right SPF 50+ or Left SPF 50+/Right SPF 100+. Assessment of erythema and pigmentation will be performed at baseline and after all natural sunlight exposure periods which will occur on at the same beach location over the course of 5 consecutive days. Subjects will be suspended from further natural light exposure periods following the observation of sunburn at any exposed body site.
Randomized, double-blinded, single-center, split body and split face, in use study under
multiple exposures to natural sunlight conditions in healthy volunteers.
Each subject will be instructed to self-apply the test products to the designated exposure
body/face sites as they normally would for sunburn protection while at the beach. Exposure
sites will be limited through the duration of the study to the face, neck, arms including
shoulders and legs from the top of the knee down. Each of the two products will be applied
exclusively to the exposure sites on the designated side of the body for the duration of the
study. Product labeling will include a color coded indicator of application side and a
standard sunscreen drug facts label containing usage directions.
The difference in the level of sunburn (erythema) protection afforded and the level of UV
(Ultraviolet) induced pigmentation (melanogenesis) response mediated by the typical usage of
SPF 50+ and SPF 100+ sunscreens will be assessed by clinical evaluation. Erythema and
melanogenic response will also be evaluated at fixed body site locations by diffuse
reflectance spectroscopy (DRS) and chromameter assessment. Subject product usage will be
tracked by recording tube weight before and after product use. Sunlight exposure behavior
will be tracked by subject activity diaries.
Solar ultraviolet radiation conditions will be recorded on a centralized stationary
radiometer.
Erythema protection afforded by the two products will be based on the bilateral sunburn
comparison of matched exposure sites and the erythema score for each exposure area.
Success criteria will be demonstration of superior sunburn protection of SPF 100+ as compared
to SPF 50+ as indicated by less sunburn on the SPF 100+ side than the SPF 50+ side (based on
bilateral sunburn comparison).
Mediation of the UV induced pigmentation response afforded by the two products will be based
on the bilateral pigmentation comparison of matched exposure sites and chromameter and DRS
measurements.
All subjects will be evaluated at baseline and at the beginning of each day.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT04290273 -
Characterisation of the Time-course Response of UV-induced Erythema
|
N/A | |
| Completed |
NCT01659853 -
Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea
|
Phase 3 | |
| Completed |
NCT00839462 -
Efficacy of Dexpanthenol in Thermic Erythema
|
Phase 2 | |
| Not yet recruiting |
NCT06016361 -
Evaluation of a Novel Amino Acid Based Moisturizing Cream as Part of the Daily Standard Skincare Regimen Recommended During Radiation Therapy
|
N/A | |
| Completed |
NCT03633877 -
Durapore vs. Hy-Tape to Secure The Endotracheal Tube
|
N/A | |
| Active, not recruiting |
NCT02876107 -
Carboplatin and Paclitaxel With or Without Panitumumab in Treating Patients With Invasive Triple Negative Breast Cancer
|
Phase 2 | |
| Completed |
NCT06369675 -
Skin Irritation Potential of MOB015B in Healthy Subjects Using a Cumulative Irritant Patch Test Design
|
Phase 1 | |
| Completed |
NCT03352323 -
An Evaluation of the Reduction in Erythema in Adult Patients With Moderate to Severe Persistent Facial Erythema Associated With Rosacea
|
Phase 3 | |
| Completed |
NCT06369727 -
Study to Evaluate the Sensitizing Potential of MOB015B in Healthy Subjects Using a Repeat Insult Patch Test Design
|
Phase 1 | |
| Completed |
NCT02832141 -
Effect of Thoracic Spine Mobilization on Sympathetic Nervous Systems
|
||
| Completed |
NCT02131636 -
Efficacy and Safety of AGN-199201 in Patients With Persistent Erythema Associated With Rosacea
|
Phase 3 | |
| Terminated |
NCT01597921 -
A DB Randomized Study of R1 and R2 WaterJel / AloeVera Jell in Prevention of Radiation Dermatitis in Breast Cancer
|
N/A | |
| Completed |
NCT01636765 -
Study of Inter- and Intra-rater Reliability of the Clinician Erythema Assessment Scale
|
||
| Completed |
NCT01124513 -
Melanin Index in Those With Fitzpatrick Skin Phototypes I-VI
|
N/A | |
| Terminated |
NCT03496584 -
Effects of Phytonutrients on Vascular Health and Skin in Obese Males
|
N/A | |
| Completed |
NCT02737592 -
A Clinical Study to Evaluate the Safety of a Personal Lubricant in Healthy Female Subjects
|
N/A | |
| Completed |
NCT03852563 -
A Study to Gain Information How Well Dexpanthenol Derma Cream Helps the Face Skin to Recover After Cosmetic Lasering
|
N/A | |
| Completed |
NCT05300542 -
Efficacy Study of a Novel Skin Health Product to Reduce an UVB Induced Erythema
|
N/A | |
| Completed |
NCT03477825 -
Pilot Study of Triphala and Rubia Cordifolia on Gut Microbiome and Skin
|
N/A | |
| Completed |
NCT02490943 -
A Pilot Study of Warm and Cold Compress to Reduce Injection Site Erythema Due to Peginterferon-beta-1a in MS
|
N/A |