NCT05497921

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Steven Baker · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

This is a single-center study 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). There will be no wash-out period during the crossover as this is not a systemic drug that has a half-life, and we expect subjects to still be exposed to the contact irritants. A crossover trial was chosen since this makes more use of a smaller trial group and removes the need for a separate parallel control group, therefore reducing trial numbers and allowing all subjects to be given the active treatment. Since contact dermatitis is a chronic condition affected by external factors the skin condition should persist long enough for the investigator to expose the subject to the experimental treatment and measure the response. Since the subjects will still be exposed to their contact irritants as part of their daily life there should be no reason to introduce a washout period and since each subject acts as their own control, any systemic spread should be compensated for.

Conditions

• Contact Dermatitis of Hand

Interventions

Type	Name	Description
DEVICE	handLITE LED device	handLITETM is a home use wearable LED phototherapy device. The device consists of a flexible silicone glove that contains red and near infrared light emitting diodes (LEDs) and a controller. The LEDs generate the light. The glove is worn on the hand and is held in place by an adjustable Velcro strap.

Timeline

• Start date: 2022-10-07
• Primary completion: 2023-09-01
• Completion: 2023-09-30
• First posted: 2022-08-11
• Last updated: 2023-10-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study