Crossover Study to Evaluate the Efficacy of LED in Treating the Signs of Contact/Irritant Dermatitis of the Hand

Completed · Not applicable

Conditions studied: Contact Dermatitis of Hand

In brief

This study is intended to be a cross over study. Subjects will treat one hand while the contralateral hand acts as a control. At the end of 6 weeks the subject will be instructed to cease treatment of the test hand and commence treatment of the control hand for 6 weeks. Efficacy will be evaluated at 6 weeks after the beginning of the treatment and 12 weeks (end of crossover).

Key facts

Study ID

NCT05497921

Run by

Steven Baker

People needed

25

Starts

2022-10-07

Expected to finish

2023-09-30

Last updated by the study team

2023-10-05

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects between the ages of 21 and 75 years
• Subject with mild to moderate no greater than 50 on the SCORAD Index or 40 on the Objective SCORAD index stable contralateral contact/irritant dermatitis of the hand.
• Subjects agree to treat only one hand at a time for 6 weeks, the other acting as a control.
• 4-week washout period has elapsed since subject received topical treatments for contact/irritant dermatitis and oral antibiotics.
• Subjects agree to use a non-mediated soap substitute supplied for their use during the study period (Syndet)
• Subjects agree to NOT use any emollients 24 hours prior to their assessment days.

You may not qualify if…

• Subjects <21 and >75years of age.
• Subject with a grading score of > than 50 on the SCORAD Index or >40 on the Objective SCORAD index)
• The subject has lichenized or urticated papules or plaques.
• Subject has exudative atopic dermatitis
• Subject has localized infection
• Subjects currently taking prescriptive corticosteroids and antibiotics (topical or systemic).
• Subjects who have received PUVA or UVB therapy or any immunosuppressive therapy I the last 8 weeks.
• Planned exposure to sun, UVA or UVB that may affect the treatment area during the study period.
• Subjects who suffer from systemic photosensitive disorder such as Lupus erythematosus, photosensitive eczema, or Albinism.
• Subjects currently taking (or a history of taking) medication known to induce photosensitivity.
• Subjects who are pregnant or planning pregnancy during the study, breastfeeding mothers.
• Subjects enrolled in another clinical trial during the same study period.
• Subjects who have participated in a clinical trial in the last 30 days.
• Subjects who have a planned hospital admission and/or surgical procedure for an illness or disease which existed before enrolment into the clinical trial and which may interfere with the course or outcome of the study.
• Subjects who have a planned vacation that would exclude them from attending follow up evaluations.
• Subject has medical or psychological condition(s) associated with a risk of poor protocol compliance (e.g., alcoholism or drug abuse).
• Subject is undergoing or is likely to undergo other treatments.

Where it is running

• Dr Glynis Ablon MD, FAAD — Manhattan Beach, California, United States

Full record on ClinicalTrials.gov

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