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

Primary Purpose

Contact Dermatitis of Hand

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

handLITE LED device

About this trial

This is an interventional treatment trial for Contact Dermatitis of Hand

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Dr Glynis Ablon MD, FAAD

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Test (device arm)

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Subjective assessment of treatment response (POEM)

Full Information

NCT ID

NCT05497921

First Posted

August 8, 2022

Last Updated

October 3, 2023

Sponsor

Steven Baker

1. Study Identification

Unique Protocol Identification Number

NCT05497921

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

October 7, 2022 (Actual)

Primary Completion Date

September 1, 2023 (Actual)

Study Completion Date

September 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Steven Baker

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Contact Dermatitis of Hand

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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).

Masking

None (Open Label)

Masking Description

PI will not know which is the treatment or control hand.

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test (device arm)

Arm Type

Other

Arm Description

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

Intervention Type

Device

Intervention Name(s)

handLITE LED device

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

at 6-weeks

Secondary Outcome Measure Information:

Title

Subjective assessment of treatment response (POEM)

Description

Subjective assessment of treatment response (POEM)

Time Frame

At 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Glynis Ablon, MD

Organizational Affiliation

ASIRC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dr Glynis Ablon MD, FAAD

City

Manhattan Beach

State/Province

California

ZIP/Postal Code

90266

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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