Atopic DermatitisEarly Phase 1NCT03688464
Treatment of Nighttime Pruritus in Atopic Dermatitis
A Early Phase 1 study testing Melatonin and Diphenhydramine in people with Atopic Dermatitis, run by University of Nebraska.
Trial summary
This study will look at melatonin vs. first generation antihistamine vs. placebo in improving nighttime itching in children with atopic dermatitis. Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Melatonin and Diphenhydramine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2019to 2 Feb 2019
- Phase
- Early Phase 1
- 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 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Physician diagnosed eczema covering more than 5% of body surface area
- Ages 2-12 years old
Who cannot join
- Sleep disorder, including underlying insomnia
- Neuropsychiatric disorder
- Condition that requires use of antihistamines
- On systemic eczema therapy or monoclonal antibody for allergic diseases
- Unable to discontinue other antihistamine use
- Autoimmune disease as melatonin is contraindicated
About this study
Official title: Efficacy of Melatonin and Diphenhydramine Versus Placebo in Treatment of Nighttime Pruritus in Atopic Dermatitis
This study will look at melatonin vs. first generation antihistamine vs. placebo in improving nighttime itching in children with atopic dermatitis.
Read the detailed description
This will be a 6 week study to determine the efficacy of melatonin vs. first generation antihistamine vs. placebo in improving nighttime pruritus in children with atopic dermatitis.
Secondary aims will include:
- Determine efficacy of melatonin vs. first generation antihistamine in management of sleep disturbance in children with atopic dermatitis
- Compare differences between treatment groups in disease improvement
- Compare differences between treatment groups in quality of life
- Conditions
- Atopic Dermatitis
- Being tested
- Melatonin, Diphenhydramine, Placebos
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Also called generic
Drug to be administered for 4 weeks. Subjects will complete surveys prior to initiation and at the end of the study that will assess severity of eczema, quality of life, severity of itch, and sleep quality.
DiphenhydramineDrug
Also called Benadryl
Drug to be administered for 4 weeks. Subjects will complete surveys prior to initiation and at the end of the study that will assess severity of eczema, quality of life, severity of itch, and sleep quality.
PlacebosDrug
Also called generic
Drug to be administered for 4 weeks. Subjects will complete surveys prior to initiation and at the end of the study that will assess severity of eczema, quality of life, severity of itch, and sleep quality.
| Study group | Role | What they receive |
|---|---|---|
| Melatonin Treatment | Active comparator | Subjects to receive melatonin 0.1 mg/kg (minimum dose of 1 mg, maximum dose of 5 mg) 30 minutes prior to bedtime (1 mg/ml oral compound suspension) for 4 weeks. Receives: Drug: Melatonin |
| Diphenhydramine Treatment | Active comparator | Subject to receive diphenhydramine 2.5 mg/ml oral liquid, dosed at 1 mg/kg at bedtime for 4 weeks. Receives: Drug: Diphenhydramine |
| Placebo | Placebo comparator | Subjects will receive cherry flavored placebo at bedtime for 4 weeks. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
POEM (Patient Oriented Eczema Measure)
This survey is a total of 7 questions that assesses the quality of life of patient's with eczema to determine their disease severity. The 7 questions are scored out of 4 points. A higher total score indicates a higher severity of disease.
Measured: 6 weeks
EASI score
This tool is also used to assess severity of eczema. 4 different body regions are scored based on the percentage of eczema affecting the area. The calculations for each region are severity score x area score x known multiplier. A higher score indicates a higher severity of disease.
Measured: 6 weeks
Secondary outcomes (3)
5D Pruritus survey
This survey is a 5 question survey to assess severity of itch in patient's with eczema. The higher the score the worse the pruritus is and the more it affects the patient on a daily basis.
Measured: 6 weeks
ESS-CHAD
This questionnaire is a series of questions that assesses sleepiness. Patient's can rank the situations based on a 3 point scale, 0 indicating would never doze and 3 indicating a high chance of dozing. A higher score indicates increased sleepiness.
Measured: 6 weeks
Actigraphy
This device is worn on the wrist of a patient like a watch and records sleep-wake cycles.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start2 Feb 2019
- Primary completion2 Feb 2019
- Study completion2 Feb 2019
Why it stopped: Study never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital and Medical Center, Omaha, Nebraska
- Responsible party
- Sponsor
- Investigators
- Kylie Liermann, DO, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688464
- Sponsor's protocol ID
- 0197-18-FB
- Status last verified
- Aug 2024
- First submitted
- 26 Sep 2018
- Last updated
- 3 Sep 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Melatonin and Diphenhydramine Versus Placebo in Treatment of Nighttime Pruritus in Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03688464
- Acronym / sponsor ID
- 0197-18-FB
- Conditions
- Atopic Dermatitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Children's Hospital and Medical Center, Omaha, Nebraska
- Study start
- 2 Feb 2019 (actual)
- Primary completion
- 2 Feb 2019 (actual)
- Study completion
- 2 Feb 2019 (actual)
- First posted
- 28 Sep 2018 (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 will look at melatonin vs. first generation antihistamine vs. placebo in improving nighttime itching in children with atopic dermatitis.
Detailed description
This will be a 6 week study to determine the efficacy of melatonin vs. first generation antihistamine vs. placebo in improving nighttime pruritus in children with atopic dermatitis.
Secondary aims will include:
- Determine efficacy of melatonin vs. first generation antihistamine in management of sleep disturbance in children with atopic dermatitis
- Compare differences between treatment groups in disease improvement
- Compare differences between treatment groups in quality of life
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Melatonin Treatment | Active comparator | Drug: MelatoninSubjects to receive melatonin 0.1 mg/kg (minimum dose of 1 mg, maximum dose of 5 mg) 30 minutes prior to bedtime (1 mg/ml oral compound suspension) for 4 weeks. |
| Diphenhydramine Treatment | Active comparator | Drug: DiphenhydramineSubject to receive diphenhydramine 2.5 mg/ml oral liquid, dosed at 1 mg/kg at bedtime for 4 weeks. |
| Placebo | Placebo comparator | Drug: PlacebosSubjects will receive cherry flavored placebo at bedtime for 4 weeks. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Physician diagnosed eczema covering more than 5% of body surface area
- Ages 2-12 years old
Key exclusion criteria (6 listed)
- Sleep disorder, including underlying insomnia
- Neuropsychiatric disorder
- Condition that requires use of antihistamines
- On systemic eczema therapy or monoclonal antibody for allergic diseases
- Unable to discontinue other antihistamine use
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 |
|---|---|---|
| MelatoninAlso: genericDrug to be administered for 4 weeks. Subjects will complete surveys prior to initiation and at the end of the study that will assess severity of eczema, quality of life, severity of itch, and sleep quality. | Drug | Melatonin Treatment |
| DiphenhydramineAlso: BenadrylDrug to be administered for 4 weeks. Subjects will complete surveys prior to initiation and at the end of the study that will assess severity of eczema, quality of life, severity of itch, and sleep quality. | Drug | Diphenhydramine Treatment |
| PlacebosAlso: genericDrug to be administered for 4 weeks. Subjects will complete surveys prior to initiation and at the end of the study that will assess severity of eczema, quality of life, severity of itch, and sleep quality. | Drug | Placebo |
Primary outcome
POEM (Patient Oriented Eczema Measure)
Time frame: 6 weeks
This survey is a total of 7 questions that assesses the quality of life of patient's with eczema to determine their disease severity. The 7 questions are scored out of 4 points. A higher total score indicates a higher severity of disease.
EASI score
Time frame: 6 weeks
This tool is also used to assess severity of eczema. 4 different body regions are scored based on the percentage of eczema affecting the area. The calculations for each region are severity score x area score x known multiplier. A higher score indicates a higher severity of disease.
3 secondary outcomes
5D Pruritus survey
Time frame: 6 weeks
ESS-CHAD
Time frame: 6 weeks
Actigraphy
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Kylie Liermann, DO principal investigator
University of Nebraska
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Melatonin and Diphenhydramine in people with Atopic Dermatitis, run by University of Nebraska.
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 2 inclusion and 6 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: withdrawn, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
POEM (Patient Oriented Eczema Measure) (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 3 Sep 2024.