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

NCT05497921 | Completed DMC FDA Device

• 1 other identifier: ASIRC_Hlcd06_02
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Contact Dermatitis of Hand

Outcome Measures

Primary Outcomes (1)

• Reduction in the signs and symptoms of contact/irritant dermatitis of the hand according to a Modified SCORAD system

  eduction in the signs and symptoms of contact/irritant dermatitis of the hand according to a Modified SCORAD system

  at 6-weeks

Secondary Outcomes (1)

• Subjective assessment of treatment response (POEM)

  At 6 weeks

Study Arms (1)

Test (device arm)

OTHER

Crossover study. The subject treats 1 hand while the contralateral is the control arm. After 6 weeks the treatment/control hand are swopped.

Device: handLITE LED device

Interventions

handLITE LED device 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.

Test (device arm)

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.

Sponsors & Collaborators

• Steven Baker: lead

Study Sites (1)

Dr Glynis Ablon MD, FAAD

Manhattan Beach, California, 90266, United States

Location

Study Officials

• Glynis Ablon, MD

  ASIRC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: PI will not know which is the treatment or control hand.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Trial Manager

Model Details: 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).

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 11, 2022
• Study Start: October 7, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 30, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)