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Dermatitis, Contact clinical trials

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NCT ID: NCT03380026 Completed - Mycosis Fungoides Clinical Trials

Mechlorethamine Induced Contact Dermatitis Avoidance Study

MIDAS
Start date: December 13, 2017
Phase: Phase 2
Study type: Interventional

This is a two-arm, open-label study that aims to compare the incidence and severity of the most common adverse reactions, particularly contact dermatitis, when Valchlor is used alone or in conjunction with triamcinolone ointment 0.1% in early stage MF subjects (Stage IA and IB) for a period of 4 months.

NCT ID: NCT03375957 Completed - Clinical trials for Sensitivity, Contact

Sensitization Study of ATx201 in Healthy Volunteers

Start date: January 8, 2018
Phase: Phase 1
Study type: Interventional

This is a Phase I, single-site study to evaluate the sensitization potential of topically applied ATx201 GEL, 2% and 4%, along with a placebo control, in healthy human subjects.

NCT ID: NCT03313232 Completed - Clinical trials for Allergic Contact Dermatitis Due to Cosmetics

Low Dose Exposure to Oxidized R-limonene - A Repeated Open Application Test (ROAT) Study

Start date: October 10, 2017
Phase: N/A
Study type: Interventional

This study evaluates the clinical and molecular effect of daily exposure to low doses of the fragrance contact allergen oxidized R-limonene. Three groups of participants are included: 1) Patients with a previous positive patch test to oxidized R-Limonene, 2) patients with a previous doubtful patch test to oxidized R-limonene and 3) healthy controls with no contact allergy to oxidized R-limonene

NCT ID: NCT03309215 Completed - Clinical trials for Allergic Contact Dermatitis Due to Nickel

Short Repeated Nickel Exposures

Start date: September 16, 2017
Phase: N/A
Study type: Interventional

The former Nickel Directive was introduced in EU in 1994 limiting the release of nickel from items intended for prolonged contact with skin. The nickel regulation entered into full force in 2001 and became a part of REACH (the EU chemicals regulation) in 2009. Since then the prevalence of nickel allergy has declined in some countries, but not in others, following the implementation. Young individuals still become allergic to nickel (2, 3) and a high prevalence of nickel allergy, exceeding 10%, is seen among young women (below 30 years) in the general population. The EU nickel regulation has been changing over time. The present limits of nickel release for metallic items intended for direct and prolonged contact with the skin is <0.5 μg/cm2/week and <0.2 μg/cm2/week for any post assemblies inserted into pierced holes. In 2014, EU defined prolonged contact with the skin as: at least 30 minutes on one or more occasions within two weeks for items with continuous skin contact, or to at least 10 minutes on three or more occasions within two weeks (7). The overall objective is to evaluate how well the EU nickel regulation protects individuals against developing nickel dermatitis. More specifically we will: 1. Study the penetration of nickel in normal and irritated skin after short repeated skin exposure under controlled temperature in nickel sensitized patients and in healthy controls 2. Reveal the potential of short repeated nickel skin exposure on normal and irritated skin to elicit dermatitis, during controlled climate factors in nickel sensitized patients and controls using the time restrictions of the definition of prolonged skin contact in the nickel regulation.

NCT ID: NCT03231813 Completed - Clinical trials for Irritant Contact Dermatitis

Regional Differences of Cutaneous Irritation and Its Effect on Skin Barrier Recovery

Start date: August 29, 2017
Phase: N/A
Study type: Interventional

Irritant contact dermatitis induced by sodium lauryl sulphate (SLS) is often used as a model for testing efficacy of various topical preparations. Aforementioned model is standardized and described in guidelines, but it is not explicitly stated where the irritation should be induced. Published clinical trials usually irritate volar aspect of forearms or upper back. Also, lower back and dorsal aspect of forearm are sometimes used. Skin parameters vary depending on anatomic location of measured skin. There is a difference in stratum corneum thickness, hydration and transepidermal water loss across different locations, including between volar forearm and upper back. Furthermore, regional difference in skin response to irritation by tape stripping and benzalkonium chloride were observed. Such differences are also possible in SLS irritation model. One study has shown higher, but not statistically significant, response of back in comparison to forearms, but it had a very small sample size (n=9). Moreover, there are regional variations of topical preparations absorption. Hydrocortisone had 1,7 times higher absorption when applied to upper back in comparison to forearms. Those variations could be explained by different corneocyte size and number of their layers between back and hands. Skin baseline properties and response to irritation seem to be dependent on anatomic position. Those differences could mean different response to treatment. Since published trials only tested efficacy of various preparations on one anatomic location, it is possible their results would be different if tested on other body parts. It could limit validity and usefulness of conducted trials. The aim of this study is to determine if there are regional differences of skin response to irritation and emollient cream treatment in irritant contact dermatitis model.

NCT ID: NCT03089775 Completed - Contact Dermatitis Clinical Trials

Evaluation of Safety and Efficacy of BBI-2000 in Treating and Preventing Contact Dermatitis

BBI
Start date: March 14, 2017
Phase: Phase 1
Study type: Interventional

This two cohort study (Cohort A and B) is being conducted to assess the safety and efficacy of BBI-2000 for the prevention (Cohort A) and treatment (Cohort B) of delayed type hypersensitivity reaction.

NCT ID: NCT02996357 Completed - Diaper Rash Clinical Trials

Risk Factors for Incontinence-Associated Dermatitis (IAD) in ICU Patients Suffering From Fecal Incontinence

Start date: October 4, 2016
Phase: N/A
Study type: Observational

This study aims to identify patient characteristics associated with the development of Incontinence-Associated Dermatitis (IAD) category 2 (skin erosion due to incontinence). 380 ICU patients suffering of fecal incontinence will be included in the study. Data on 19 possible risk factors will be collected at one point in time by the research team. Different sources and methods will be used to collect patient data: skin assessment, patient record, direct patient observation, routine blood samples.

NCT ID: NCT02700373 Completed - Contact Dermatitis Clinical Trials

A Phase I, Single-Center Study of PDC-APB in Healthy Volunteers

Start date: March 2016
Phase: Phase 1
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, single ascending dose study to assess the safety and tolerability of PDC-APB by intramuscular (IM) injection compared to placebo.

NCT ID: NCT02534441 Completed - Clinical trials for Allergic Contact Dermatitis

Epidemiology and Co-Reactivity of Novel Surfactant Allergens

Start date: August 2015
Phase: N/A
Study type: Interventional

The primary objectives of this study are to identify positivity rates to three novel surfactants (ingredients used in soaps, detergents, and other cleansers that serve to lower the surface tension of the skin and remove debris) and co-reactivity with other surfactants in patients with known surfactant sensitivity on skin patch testing. The investigators hypothesize that subjects who previously tested positive to known allergenic surfactants (cocamidopropyl betaine, stearamidopropyl dimethylamine, dimethylaminopropylamine, coconut diethanolamide, oleamidopropyl dimethylamine, and decyl glucoside) may demonstrate co-reactivity to the three novel surfactant sensitizers (sodium lauroyl sarcosinate, isostearmidopropyl morpholine lactate, and disodium lauroamphodiacetate) on skin patch testing.

NCT ID: NCT02028208 Completed - Contact Dermatitis Clinical Trials

Clinical Evaluation of Metal Panel Allergens: Mercury, Aluminum and Palladium Dose Response Study

Start date: November 4, 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the diagnostic performance and safety of ascending doses of mercury, aluminum and palladium metal allergens proposed for inclusion in a metal allergen panel. Optimal dose will be selected based on the lowest dose of each allergen eliciting a positive response in 70-90% of subjects tested.