Contact Dermatitis of HandNCT05497921
Crossover Study to Evaluate the Efficacy of LED in Treating the Signs of Contact/Irritant Dermatitis of the Hand
A study testing handLITE LED device in people with Contact Dermatitis of Hand, run by Steven Baker at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Contact Dermatitis of Hand
- What is being tested?
- handLITE LED device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dr Glynis Ablon MD, FAAD
Manhattan Beach, California, 90266
About this study
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
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).
Read the 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
- Being tested
- handLITE LED device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
handLITE LED deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: handLITE LED device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 6-weeks
Secondary outcomes (1)
Subjective assessment of treatment response (POEM)
Subjective assessment of treatment response (POEM)
Measured: At 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start7 Oct 2022
- Primary completion1 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact Dermatitis of HandStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steven Baker
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Steven Baker, Ismart
- Investigators
- Glynis Ablon, MD, Principal investigator, ASIRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497921
- Sponsor's protocol ID
- ASIRC_Hlcd06_02
- Status last verified
- Oct 2023
- First submitted
- 8 Aug 2022
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05497921
- Acronym / sponsor ID
- ASIRC_Hlcd06_02
- Conditions
- Contact Dermatitis of Hand
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Steven BakerIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| Test (device arm) | Other | Device: handLITE LED deviceCrossover study. The subject treats 1 hand while the contralateral is the control arm. After 6 weeks the treatment/control hand are swopped. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| handLITE LED devicehandLITETM 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. | Device | Test (device arm) |
Primary outcome
Reduction in the signs and symptoms of contact/irritant dermatitis of the hand according to a Modified SCORAD system
Time frame: at 6-weeks
eduction in the signs and symptoms of contact/irritant dermatitis of the hand according to a Modified SCORAD system
1 secondary outcome
Subjective assessment of treatment response (POEM)
Time frame: At 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Contact Dermatitis of Hand
Active, not recruitingObservational study
Methotrexat to Hand Eczema in the BIOSKIN Cohort
Atopic Dermatitis, Contact Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glynis Ablon, MD principal investigator
ASIRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing handLITE LED device in people with Contact Dermatitis of Hand, run by Steven Baker at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the signs and symptoms of contact/irritant dermatitis of the hand according to a Modified SCORAD system (time frame: at 6-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.