Treatment Trials

125 Clinical Trials for Various Conditions

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COMPLETED
A Study to Evaluate Usage of Mineral Sunscreens With Differentiated Whitening Attributes in Multi-Cultural Skin Tones
Description

The purpose of the study is to evaluate the whitening potential of different mineral and chemical sunscreens across multi-cultural skin tones through instrumentation, imaging, and self-assessment. It also aimed to evaluate the relationship between self-perception and objective measurements of whitening.

Conditions
COMPLETED
A Study to Evaluate the Whitening Effect of Mineral Sunscreens in Multi-Cultural Skin Tones
Description

The purpose of this study is to evaluate the whitening potential effect of different mineral sunscreens across multi-cultural skin tones through instrumentation, imaging, and self-assessment and also evaluate the relationship between self-perception and objective measurement of whitening.

Conditions
COMPLETED
Cost and Quality in Consumer Sunscreen Preferences
Description

This study seeks to determine what price consumers are willing to pay for a sunscreen product containing their ideal combination of attributes or qualities. This study will assess consumer preferences for various sunscreen qualities, as well as the relative contribution of each preference to the consumer's monetary valuation of a complete sunscreen product. The hypothesis is that respondents' willingness to pay for each sunscreen attribute will vary by demographic characteristics, especially self-identified race and socioeconomic class

Conditions
COMPLETED
Assessment of the Human Systemic Absorption of Sunscreen Ingredients
Description

This study is designed to assess the systemic exposure and pharmacokinetics of sunscreen active ingredients (avobenzone, oxybenzone, ecamsule, octocrylene homosalate, octisalate and octinoxate) when sunscreen product is applied under maximal use conditions. Part 1 is an open-label, randomized, 4-arm study in 24 healthy adult subjects with the primary objective to explore whether the active components (avobenzone, oxybenzone, ecamsule and octocrylene) of 4 sunscreen products (1 sunscreen product in each arm) are absorbed into the systemic circulation when a sunscreen product is applied under maximal use conditions. One sunscreen product with the highest avobenzone exposure will be selected for the second part of the study. If there is no quantifiable exposure of avobenzone for any of the sunscreen products, the formulation with the highest oxybenzone exposure will be selected for Part 2. In addition, 3 new sunscreen products are included in Part 2. Part 2 is an open label, 4-arm study in 48 healthy adult subjects with the primary objective to assess the pharmacokinetics of the active components in the selected product from Part 1 and 3 additional products with a combination of active ingredients (avobenzone, oxybenzone, octocrylene, ecamsule homosalate, octisalate and octinoxate as applicable/contained in the different products).

COMPLETED
A Sunscreen Based on Bioadhesive Nanoparticles
Description

The initial focus of the study will be on safety, sun protection factor (SPF) characterization, and substantivity (duration of protection) studies. The primary outcome of the study will be to measure the sun protection factor (SPF) of a bioadhesive nanoparticles (BNP) formulation in 20-25 healthy volunteers with fair skin.

COMPLETED
Comparison Of Video-based Versus Written Patient Education on Sunscreen
Description

The purpose of this study is to compare the effect of video-based patient education with written instruction on subjects' adherence to sunscreen application.

COMPLETED
Evaluation of Adherence to Topical Agents: Applying Communication Technology to Improve Sunscreen Use
Description

The purpose of this study is to determine if using an electronic reminder improves adherence to sunscreen use. The specific study aims are as follows: 1. To determine whether the use of electronic reminder system increases adherence to topical agents. 2. To assess technological feasibility of measuring adherence to topical agents using electronic monitors specially designed for tubes. 3. To assess technological feasibility of providing electronic reminders using cellular phone text-messaging system. 4. To obtain subjects' feedback on the adherence monitoring and reminder system.

Conditions
COMPLETED
A Twelve Week Clinical Study to Evaluate the Efficacy and Tolerability of a Sunscreen Moisturizer SPF 50+
Description

The primary objective of this study is to evaluate the efficacy and tolerance of a moisturizer SPF 50+ when used over a 12-week time period by women with moderate to severe facial photodamage.

ACTIVE_NOT_RECRUITING
Impact of Sunscreen Dispensers in Parks Visited by Teenagers
Description

This study will evaluate the use of publicly available free sunscreen dispensers at Maine beaches and Boston and Cambridge parks. Aim 1: Determine the impact of DFS+ (dispensers, flyers, enhanced signage, + a social media component delivered by teen ambassadors) sun protection education on the use of free sunscreen dispensers by adolescents ages 12-20 compared with DFS (dispensers, flyers, standard signage). Aim 2: Outcomes evaluation to assess the effects of the sunscreen dispensers and the sun-safety educational intervention on sun protection knowledge, attitudes, beliefs, and behaviors within the community. Aim 3: Cost Evaluation and Cost-Effectiveness Analysis

COMPLETED
Water Immersion Studies of a Long-wear Sunscreen to Improve Protection Against Ultraviolet Radiation
Description

This study is designed to determine the Sun Protection Factor (SPF) of a test product following 80 Minute Water Immersion methodology defined in Final Monograph - Code of Federal Regulations Title 21 - "Labeling and Effectiveness Testing; Sunscreen Drug Products; Required Labeling Based on Effectiveness Testing", Final Rule, 21 CFR 201.327.(j)

Conditions
COMPLETED
Assessing a Natural Product Plus Bioadhesive Nanoparticle (BNP) Sunscreen
Description

The primary objective of this study is to evaluate the effects of a novel sunscreen formulation by assessing the extent of ultraviolet radiation (UVR)-induced direct and indirect cellular and DNA damage to human skin, in the presence vs absence of the sunscreen, in a population of healthy adults with fair skin (Fitzpatrick Scale type I, II or III).

Conditions
COMPLETED
Pharmacokinetic (PK) Evaluation of Bemotrizinol (6%) in a Sunscreen Maximum Usage Trial
Description

An open-label, randomized, 3-arm study in 162 healthy adult subjects with the following primary objective: To assess the systemic absorption and pharmacokinetics of BEMT from 3 market image sunscreen formulations under maximal-use conditions.

COMPLETED
Clinical Study to Evaluate the 80-Minute Water Resistant Sun Protection Factor (SPF) of Sunscreen Products
Description

The purpose of this study is to determine the 80-Minute Water Resistant SPF of three sunscreen products (ChapStick Active Performance \[CAP\] UnScented, CAP Herbal Mint Flavour and CAP Mountain Berry Flavour) using the methodology described in the Food and Drug Administration (FDA) Final Rule (2011).

COMPLETED
Clinical Study to Evaluate the Efficacy of an Over-the-counter (OTC) Sunscreen Lip Balm Product
Description

The purpose of this study is to evaluate the 8-hour moisturization efficacy of OTC sunscreen lip balm after a single treatment application.

COMPLETED
Clinical Study to Evaluate the Sun Protection Factor (SPF) of Three Sunscreen Products
Description

The purpose of this study is to determine the static SPF of three sunscreen products (ChapStick Active Performance \[CAP\] UnScented, CAP Herbal Mint and CAP Mountain Berry) using the methodology described in the Food and Drug Administration (FDA) Final Rule (2011).

COMPLETED
Clinical Study to Evaluate the Sun Protection Factor (SPF) of Sunscreen Products
Description

The purpose of this study is to determine the static SPF of three sunscreen products (ChapStick Lip Moisturizer \[CLM\] Original, CLM Mint Flavour and CLM Black Cherry Flavour) using the methodology described in the Food and Drug Administration (FDA) Final Rule (2011).

COMPLETED
Clinical Study to Evaluate the Efficacy of an Over-the-counter (OTC) Sunscreen Lip Balm
Description

The purpose of this study is to evaluate the 8-hour moisturization efficacy of OTC sunscreen lip balm after a single treatment application.

COMPLETED
Sun Protection Factor (SPF) Determination of Two Sunscreen-Containing Lip Balms
Description

The aim of this study is to determine the SPF of two test materials ChapStick Moisturizer, Classic Flavor and ChapStick Moisturizer, Strawberry Flavor using the methodology described in the International Standard Test Method. This static methodology also meets the requirements of the Australia/New Zealand standard.

COMPLETED
The Effect of Topical Sunscreen Plus Antioxidant Against the Visible Light Biological Effects
Description

Visible light is known to induce pigmentation in darker skin types. The investigators aim to study the effects of visible light on the skin after topical application of sunscreen plus antioxidant.

Conditions
COMPLETED
Evaluation of a Gel Sunscreen in Controlled Use Conditions (208/2016)
Description

To explore and quantify potential issues with application of a gel sunscreen in Outdoor Use testing, in a controlled indoor environment

ENROLLING_BY_INVITATION
Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics
Description

The purpose of this study is to assess how human skin reacts and how sunscreens and sun protection fabrics protect in natural sunlight compared to their labeled claims, indoor testing methods (existing or modified) and instructions.

COMPLETED
Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating (821/2016)
Description

To visually evaluate the retention of coverage of the Test Product(s) (TP) on the face after exercise compared to the full coverage observed prior to exercise

COMPLETED
Supervised Outdoor-Use Test For Sunscreen Products in Adults
Description

To assess the safety of a sunscreen product under supervised outdoor-use conditions

COMPLETED
To Test for Photo Allergy Reaction of Sunscreens
Description

The primary objective of this tudy was to evaluate the potential of photoallergy of of sun care products Sun Protection Factor (SPF) 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 application compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB. The secondary objective aims for evaluation of the safety of SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 combined with ultraviolet (UV) A/B irradiation by monitoring adverse events (AEs) throughout the study.

Conditions
COMPLETED
Evaluation of the Stinging Potential of Sunscreen Products in Human Eyes
Description

The objective of this study was to compare the human eye stinging potential of experimental formulas and an industry standard shampoo mixture. The study was conducted under the supervision of a Board Certified Ophthalmologist.

COMPLETED
Supervised Outdoor-Use Test to Assess the Safety of a Sunscreen C-Spray on Sport Users
Description

The objective of this study was to assess the safety and appropriateness of a sunscreen product for use on sport users, under supervised outdoor-use conditions. The study was conducted under the supervision of a Board-Certified Dermatologist at an outdoor, chlorinated swimming pool facility.

COMPLETED
Evaluation of the Irritation Potential of Sunscreen Products in Human Eyes
Description

Evaluation of the human eye irritation potential of a test sunscreen formulation.

COMPLETED
Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating
Description

To visually evaluate the retention of coverage of the Test Product(s) (TP) on the face after exercise compared to the full coverage observed prior to exercise.

COMPLETED
Outdoor-Use Test for Sunscreen Products in Children Ages 3 to 9 Years Old
Description

To assess the safety of a sunscreen product under supervised outdoor-use conditions with the target consumer

COMPLETED
To Assess the Safety of a Sunscreen Product
Description

The objective of this study was to assess the safety and appropriateness of a sunscreen product for use on sport users, under supervised outdoor use conditions.