Atopic DermatitisNCT04444726
Phototherpy Versus Tapwater Iontophoresis for Management of Atopic Dermatitis in Children.
A study testing Ultra Violet A Device.+ Topical medical treatment, Iontophoresis device + Topical medical treatment and Topical medical treatment (Betamethasone dipropionate 0.05% " diprolene " ) in people with Atopic Dermatitis, run by Cairo University at 1 site in Egypt.
Trial summary
this study is conducted to compare the effect of phototherapy" psoralen plus UVA " bath puva to tap water iontophoresis in the treatment of atopic dermatitis in children. Read more about this study
- Who is it for?
- Ages 9 to 16 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Ultra Violet A Device.+ Topical medical treatment, Iontophoresis device + Topical medical treatment and Topical medical treatment (Betamethasone dipropionate 0.05% " diprolene " )
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2019to 21 Nov 2020
- 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 9 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 9 to 16 years.
- Suffering from AD of dyshidrotic as well as dry types of more than 6-months duration
- Traditional types of treatment options, including oral or topical corticosteroids, proved ineffective.
Who cannot join
- Intolerance history to UV radiation.
- Skin malignancy at the area to be treated.
- Acute infection at the treated area.
- Children received radiotherapy in the area to be treated during the last 6 months.
- Children received corticosteroid therapy topically within 14 days before treatment, or systemic corticosteroids or any immunosuppressive drugs within the last 4 weeks.
- Circulatory and sensory disorders and children with diabetes mellitus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phototherpy Versus Tap Water Iontophoresis for Management of Atopic Dermatitis in Children, Randomized Clinical Trial.
this study is conducted to compare the effect of phototherapy" psoralen plus UVA " bath puva to tap water iontophoresis in the treatment of atopic dermatitis in children.
Read the detailed description
Sixty children were selected from the department of dermatology, Banha University Hospital. Patients were randomly assigned to (Group- A):- 20 children Patients, aged between 6-16 years old. be treated with Phototherapy, for 3 sessions per week for 8 weeks Plus the traditional medical treatment. which is the betamethasone dipropionate 0.05% " diprolene for 2 times a day for 8 weeks. (Group B): 20 children Patients, in Group-B are treated with tap water iontophoresis, for 8 weeks, 3 sessions /week: the intensity were increased according to the patient's tolerance, for 20 minutes. Plus the traditional medical treatment. (Group -C) the control group will treated by only the traditional medical treatment which is the betamethasone dipropionate 0.05% " diprolene" cream, two times a day for 8 weeks Skin thickness by ultrasonography and Patient Oriented Eczema Measure(POEM) are measured before and after 8 weeks of treatment.
- Conditions
- Atopic Dermatitis
- Being tested
- Ultra Violet A Device.+ Topical medical treatment, Iontophoresis device + Topical medical treatment, Topical medical treatment (Betamethasone dipropionate 0.05% " diprolene " )
- Keywords
- Atopic dermatitis, Phototherapy, iontophoresis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra Violet A Device.+ Topical medical treatmentDevice
Hands of the patient are irradiated in the UVA device after soaking for 20 minutes into 10 litres of water containing psoralen "meladenine capsule".
Iontophoresis device + Topical medical treatmentDevice
Tap-water iontophoresis was given 3 times weekly for 10 min. The direct current level was slowly increased, guided by the occurrence of tingling sensations. The maximum level was 30 mA.
Topical medical treatment (Betamethasone dipropionate 0.05% " diprolene " )Drug
thin film of the cream is being applied to the affected areas for 2 times per day.
| Study group | Role | What they receive |
|---|---|---|
| Phototherapy "PUVA" +traditional medical treatmentn | Experimental | patient sock his hands in a bath containing water with the constitution of psoralen "meladinine " capsule for 20 minutes then irradiated at the UVA device for 3 sessions per week for 8 weeks Plus the traditional medical treatment. which is the betamethasone dipropionate 0.05% " diprolene for 2 times a day for 8 weeks. Receives: Device: Ultra Violet A Device.+ Topical medical treatment; Drug: Topical medical treatment (Betamethasone dipropionate 0.05% " diprolene " ) |
| Tap Water Iontophoresis + Traditional medical treatment | Experimental | Tap-water iontophoresis was given 3 times weekly for 10 min The direct current level was slowly increased, guided by the occurrence of tingling sensations. The maximum level was 30mA. Plus the traditional medical treatment. which is the betamethasone dipropionate 0.05% " diprolene for 2 times a day for 8 weeks. Receives: Device: Iontophoresis device + Topical medical treatment; Drug: Topical medical treatment (Betamethasone dipropionate 0.05% " diprolene " ) |
| traditional medical treatment | Active comparator | Traditional medical treatment. which is the betamethasone dipropionate 0.05% " diprolene for 2 times a day for 8 weeks. Receives: Drug: Topical medical treatment (Betamethasone dipropionate 0.05% " diprolene " ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Oriented Eczema Measure" POEM"
The severity of eczema was estimated by asking young children to complete the questionnaire with the help of their parents. They were asked to leave blank any questions you feel unable to answer.
Measured: 8 weeks of treatment
Secondary outcomes (1)
Thickness of the skin " Ultrasonography"
Assessment of the skin thickness was done using the ultrasonography 7.5 MHz. The ultrasound imaging system was used to measure the thickness of the skin at the affected site
Measured: 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start20 Jan 2019
- Primary completion20 Nov 2020
- Study completion21 Nov 2020
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 Cairo UniversityThe 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olfat Ibrahim Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444726
- Sponsor's protocol ID
- 2776
- Status last verified
- Jun 2021
- First submitted
- 20 Jun 2020
- Last updated
- 10 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared after 6 month of publication .
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phototherpy Versus Tap Water Iontophoresis for Management of Atopic Dermatitis in Children, Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04444726
- Acronym / sponsor ID
- 2776
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Phototherapy, iontophoresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jan 2019 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 21 Nov 2020 (actual)
- First posted
- 23 Jun 2020 (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 conducted to compare the effect of phototherapy" psoralen plus UVA " bath puva to tap water iontophoresis in the treatment of atopic dermatitis in children.
Detailed description
Sixty children were selected from the department of dermatology, Banha University Hospital. Patients were randomly assigned to (Group- A):- 20 children Patients, aged between 6-16 years old. be treated with Phototherapy, for 3 sessions per week for 8 weeks Plus the traditional medical treatment. which is the betamethasone dipropionate 0.05% " diprolene for 2 times a day for 8 weeks. (Group B): 20 children Patients, in Group-B are treated with tap water iontophoresis, for 8 weeks, 3 sessions /week: the intensity were increased according to the patient's tolerance, for 20 minutes. Plus the traditional medical treatment. (Group -C) the control group will treated by only the traditional medical treatment which is the betamethasone dipropionate 0.05% " diprolene" cream, two times a day for 8 weeks Skin thickness by ultrasonography and Patient Oriented Eczema Measure(POEM) are measured before and after 8 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phototherapy "PUVA" +traditional medical treatmentn | Experimental | Device: Ultra Violet A Device.+ Topical medical treatment, Drug: Topical medical treatment (Betamethasone dipropionate 0.05% " diprolene " )patient sock his hands in a bath containing water with the constitution of psoralen "meladinine " capsule for 20 minutes then irradiated at the UVA device for 3 sessions per week for 8 weeks Plus the traditional medical treatment. which is the betamethasone dipropionate 0.05% " diprolene for 2 times a day for 8 weeks. |
| Tap Water Iontophoresis + Traditional medical treatment | Experimental | Device: Iontophoresis device + Topical medical treatment, Drug: Topical medical treatment (Betamethasone dipropionate 0.05% " diprolene " )Tap-water iontophoresis was given 3 times weekly for 10 min The direct current level was slowly increased, guided by the occurrence of tingling sensations. The maximum level was 30mA. Plus the traditional medical treatment. which is the betamethasone dipropionate 0.05% " diprolene for 2 times a day for 8 weeks. |
| traditional medical treatment | Active comparator | Drug: Topical medical treatment (Betamethasone dipropionate 0.05% " diprolene " )Traditional medical treatment. which is the betamethasone dipropionate 0.05% " diprolene for 2 times a day for 8 weeks. |
Who may qualify
- Ages
- 9 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age between 9 to 16 years.
- Suffering from AD of dyshidrotic as well as dry types of more than 6-months duration
- Traditional types of treatment options, including oral or topical corticosteroids, proved ineffective.
Key exclusion criteria (6 listed)
- Intolerance history to UV radiation.
- Skin malignancy at the area to be treated.
- Acute infection at the treated area.
- Children received radiotherapy in the area to be treated during the last 6 months.
- Children received corticosteroid therapy topically within 14 days before treatment, or systemic corticosteroids or any immunosuppressive drugs within the last 4 weeks.
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 |
|---|---|---|
| Ultra Violet A Device.+ Topical medical treatmentHands of the patient are irradiated in the UVA device after soaking for 20 minutes into 10 litres of water containing psoralen "meladenine capsule". | Device | Phototherapy "PUVA" +traditional medical treatmentn |
| Iontophoresis device + Topical medical treatmentTap-water iontophoresis was given 3 times weekly for 10 min. The direct current level was slowly increased, guided by the occurrence of tingling sensations. The maximum level was 30 mA. | Device | Tap Water Iontophoresis + Traditional medical treatment |
| Topical medical treatment (Betamethasone dipropionate 0.05% " diprolene " )thin film of the cream is being applied to the affected areas for 2 times per day. | Drug | Phototherapy "PUVA" +traditional medical treatmentn, Tap Water Iontophoresis + Traditional medical treatment, traditional medical treatment |
Primary outcome
Patient Oriented Eczema Measure" POEM"
Time frame: 8 weeks of treatment
The severity of eczema was estimated by asking young children to complete the questionnaire with the help of their parents. They were asked to leave blank any questions you feel unable to answer.
1 secondary outcome
Thickness of the skin " Ultrasonography"
Time frame: 8 weeks of treatment
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 10 Jun 2021.
- Individual participant dataSharing planned: Yes. Data will be shared after 6 month of publication .
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultra Violet A Device.+ Topical medical treatment, Iontophoresis device + Topical medical treatment and Topical medical treatment (Betamethasone dipropionate 0.05% " diprolene " ) in people with Atopic Dermatitis, run by Cairo University at 1 site in Egypt.
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 3 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: finished, as of the sponsor's last update on 10 Jun 2021. 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 Egypt. 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?
Patient Oriented Eczema Measure" POEM" (time frame: 8 weeks of treatment). 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 10 Jun 2021.