Multiday Beach Study

2017-02-03 09:23:38 | BioPortfolio


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 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 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.

Study Design




50/100, 100/50




Johnson & Johnson Consumer and Personal Products Worldwide

Results (where available)

View Results


Published on BioPortfolio: 2017-02-03T09:23:38-0500

Clinical Trials [53 Associated Clinical Trials listed on BioPortfolio]

Duration of Antibiotic Treatment of Erythema Migrans

The purpose of this study is to compare the efficacy of 15-day versus 10-day doxycycline treatment in patients with erythema migrans.

A Multicenter, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Once Daily Mirvaso® Gel in Patients With Chronic Persistent Vascular Facial Erythema.

This study evaluates the efficacy of Mirvaso® in the treatment of chronic persistent vascular facial erythema, after 4 weeks of treatment, by the Clinician erythema assessment.

Minimal Erythema Dose of UV-B in Normal Population of Taiwan

There is no previous study on the minimal erythema dose of UVB irradiation in Chinese people. We will investigate the correlation of skin phototype, constitutive skin color, facultative sk...

Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Persistent Facial Erythema

The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel 0.5% applied topically once daily for 29 days versus vehicle control, in subjects with moderate...

An Evaluation of the Reduction in Erythema in Adult Patients With Moderate to Severe Persistent Facial Erythema Associated With Rosacea

the study will measure the decrease in redness on the face of rosacea subjects

PubMed Articles [104 Associated PubMed Articles listed on BioPortfolio]

Urticaria vasculitis in a child: a case report and literature review.

Annular urticarial lesions in a child must establish a main differential diagnosis with urticaria multiforme, common urticaria, acute hemorrhagic edema of infancy, erythema marginatum, erythema annula...

Ultraviolet erythema: dose response and mediator diffusion.

The earliest contribution made by Jan van der Leun to the field of photobiology was studying the mechanism of UV-induced erythema in human skin - a subject he chose for his PhD in the 1960s. His contr...

Clinical Pharmacokinetics of Oxymetazoline Cream Following Topical Facial Administration for the Treatment of Erythema Associated With Rosacea.

Oxymetazoline cream 1.0% is FDA-approved for the topical treatment of persistent facial erythema associated with rosacea in adults. This phase 2, multicenter, randomized, double-blind, parallel-group ...

Erythema multiforme triggered by Treponema pallidum infection in an HIV-infected patient.

We are currently facing a worldwide epidemic of syphilis. Clinical manifestations that are rarely seen have been encountered, leading the dermatologist to confront unusual clinical conditions in daily...

Recall erythema phenomenon following Er:YAG laser treatment: two case studies and literature review.

Recall erythema is a phenomenon occurring when an area of epidermis treated with laser is later exposed to a trigger, most often sunlight or hot water, causing erythema in the zone of laser treatment ...

Medical and Biotech [MESH] Definitions

A deep type of gyrate erythema that follows a bite by an ixodid tick; it is a stage-1 manifestation of LYME DISEASE. The site of the bite is characterized by a red papule that expands peripherally as a nonscaling, palpable band that clears centrally. This condition is often associated with systemic symptoms such as chills, fever, headache, malaise, nausea, vomiting, fatigue, backache, and stiff neck.

Redness of the skin produced by congestion of the capillaries. This condition may result from a variety of causes.

The type species of ERYTHROVIRUS and the etiological agent of ERYTHEMA INFECTIOSUM, a disease most commonly seen in school-age children.

An injury to the skin causing erythema, tenderness, and sometimes blistering and resulting from excessive exposure to the sun. The reaction is produced by the ultraviolet radiation in sunlight.

Recurrent localized itching, swelling and painful erythema on the fingers, toes or ears, produced by exposure to cold. It is also called pernio.

More From BioPortfolio on "Multiday Beach Study"

Quick Search


Relevant Topics

Mirvaso (brimonidine)
MIRVASO® (BRIMONIDINE) TOPICAL GEL, 0.33%* IS THE FIRST & ONLY FDA-APPROVED TREATMENT DEVELOPED AND INDICATED FOR PERSISTENT FACIAL REDNESS OF ROSACEA Mirvaso® (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for th...

Joint Disorders
A joint is where two or more bones come together, like the knee, hip, elbow, or shoulder. Joints can be damaged by many types of injuries or diseases, including Arthritis - inflammation of a joint causes pain, stiffness, and swelling with ...

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Searches Linking to this Trial