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Dermatitis, Photoallergic clinical trials

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NCT ID: NCT04532164 Completed - Clinical trials for Dermatitis, Photoallergic

Study to Find Out if Cream V61-044 Used to Treat Fungal Infections Causes an Allergic Skin Reaction to Sunlight in Healthy Participants

Start date: June 10, 2013
Phase: Phase 3
Study type: Interventional

Allergic skin reaction can be produced by the combination of a chemical product applied to the skin and ultraviolet (UV) radiation (a type of invisible light that comes from the sun and other light sources and can hurt your skin and eyes) received by the person. The researchers in this study wanted to find out if cream V61-044 might cause an allergic skin reaction to sunlight when applied to the skin in healthy participants. Cream V61-044 (brand name: LOTRIMIN ULTRA) is an approved drug used to treat infections caused by fungi (small growing organisms such as mold, mildew, yeast or mushrooms). Participants joining this study underwent two study phases: in Induction phase, participants received the test cream and UV radiation twice a week for 3 weeks; after 10 days of rest, in Challenge phase participants received the test cream and UV radiation once again. In both phases, the test cream was applied to two test areas on the upper back of the participants and to one of the test area UV radiation was applied. Evaluation on the skin rash was conducted two days after each UV radiation.

NCT ID: NCT04332445 Completed - Clinical trials for Sensitivity, Contact

Dermatological Assessment of Primary Dermal Irritability Accumulated, Sensitization, Photoallergy and Phototoxicity.

Start date: October 26, 2020
Phase: N/A
Study type: Interventional

This is a clinical study for health care product safety assessment. The research is going to conducted with 55 subjects, aged 18 to 70 years. The product is applied on the right and/or left participant back. After a wash out, the product is reapplied. Medical evaluation will be available throughout the study to assess possible adverse events. The main of the study is to observe the effects of the application of the product on the skin and prove the absence of irritability and/or allergy, photoallergy and phototoxicity.

NCT ID: NCT04250623 Completed - Clinical trials for Sensitivity, Contact

Dermatological Assessment of Photoallergy and Phototoxicity

Start date: April 12, 2021
Phase: N/A
Study type: Interventional

This is a clinical study for health care product safety assessment. The research will be conducted with 40 subjects*, aged 18 to 70 years. The product will be applied on the right and/or left participant back for 3 consecutive weeks. After 10 days, will have another application of the same product, which will be removed in 24 hours. Medical evaluation will be available throughout the study to assess possible adverse events. The objective of the study is to observe the effects of the application of the product on the skin and prove the absence of photoallergy and phototoxicity. * 29 completed the trial

NCT ID: NCT03899064 Completed - Photoallergy Clinical Trials

Evaluation of Potential Development of Photoallergic Skin Reaction After Use of MC2-01 Cream

Start date: February 13, 2019
Phase: Phase 1
Study type: Interventional

This trial is a 6-week, Randomized study evaluating the potential of MC2-01 Cream to induce a photoallergic skin reaction in Healthy subjects, using a controlled photopatch test design.

NCT ID: NCT03812887 Recruiting - Photoallergy Clinical Trials

Photopatch Test Study (POST Study)

POST
Start date: September 1, 2018
Phase:
Study type: Observational

In the year 2000, a group of specialists with an interest in contact dermatitis and photobiology/photophysics set up a taskforce under the umbrella of the European Society for Contact Dermatitis and the European Society for Photodermatology. This came about as a result of an awareness, that photopatch testing was under-used, there were inconsistencies in methodology and scoring of results, and there was a lack of up-to-date choice of test photoallergens. A consensus on the methodology of photopatch testing arose from this, although some inconsistencies on the methodology could not be solved and variations on the technique were accepted. Since then a European multicentre photopatch test study (EMCPPTS) was conducted in 30 clinics from 2008-2011. The EMCPPTS test agents comprised 19 UV absorbers, and 5 topical non-steroidal anti-inflammatory drugs available in Europe. More than 1,000 patients took part in this study that showed that ketoprofen and related chemicals and classical UV-filters were the main photoallergens. Since then the taskforce have met again (2012) and on the basis of the results of the ECMPPTS, on previous publications reporting cases of photoallergic contact dermatitis, and on the presence or absence of these agents in consumer products within the European market or other accessible markets, 20 substances were chosen to form the baseline European photopatch test series. Fifteen additional substances were chosen to be included in the extended photopatch test series which may be used as an additional screen alongside patients' own product. Twenty-six other agents that are no longer produced or are no longer used in the European markets have been considered to be no longer relevant for regular photopatch testing and were removed. It was suggested from this taskforce that the study should be repeated in approximately five years, as it is expected that new photoallergens will continue to emerge despite pre-marketing screening measures. Therefore members of this taskforce subsequently met in 2015, to discuss the aim of performing a very similar study, commencing in 2016. However, the investigators aim to focus specifically on methodology as in all previous studies a variety of methods of photopatch testing have been utilised. The investigators therefore aim to improve standardisation of this test. This agreed methodology will therefore enable better comparative studies in the future and hopefully encourage greater numbers of would-be users of this form of patch testing, as due to a previous level of uncertainty, many general dermatologists have been discouraged from using this technique.

NCT ID: NCT03183518 Completed - Skin Care Clinical Trials

To Assess the Photosensitisation and Photoallergy Potential of a Cosmetic Facial Product in Healthy Participants

Start date: March 27, 2017
Phase: N/A
Study type: Interventional

To evaluate the skin irritation and sensitization potential of a cosmetic facial product, under exaggerated conditions of use with controlled product application and under supervision of a dermatologist.

NCT ID: NCT02962869 Completed - Sunscreening Agents Clinical Trials

Human Photoallergy Test (824/2016)

Start date: November 3, 2016
Phase: N/A
Study type: Interventional

To evaluate the potential of a test material to produce a photoallergic response

NCT ID: NCT02872220 Completed - Photoallergy Clinical Trials

To Test for Photo Allergy Reaction of Sunscreens

Start date: March 23, 2015
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT02751515 Completed - Sunscreening Agents Clinical Trials

Human Photoallergy Test

Start date: May 2016
Phase: N/A
Study type: Interventional

To evaluate the potential of a test material to produce a photoallergic response.

NCT ID: NCT02751463 Completed - Sunscreening Agents Clinical Trials

18850 - Human Photoallergy Test

Start date: May 9, 2016
Phase: N/A
Study type: Interventional

To evaluate the potential of a test material to produce a photoallergic response.