Chronic Atopic DermatitisNCT04955951
Ultrasonographic Response to Polarized Light Therapy in the Treatment of Atopic Dermatitis
An observational study of Chronic Atopic Dermatitis, run by Ahram Canadian University at 1 site in Egypt.
Trial summary
Non-atopic dermatitis (NAD) or eczema is a common inflammatory condition; potentially debilitating that can compromise quality of life. It is usually seen in childhood, but can onset within or persist into adulthood. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men only
- Conditions the study is for
- Chronic Atopic Dermatitis
- What is being tested?
- polarized light and Topical corticosteroid ointment
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to 15 Jan 2022
- Phase
- Observational
- 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 20 to 30 years
- Men only
- No healthy volunteers
- Adult
Study population: The Patient will be referred to physical therapy outpatient clinic, faculty of physical therapy, Ahram Canadian University from dermatology out-clinics in Sheikh Zayed Hospital.
Who may be able to join
- The patients' ages will ranged from 20 to 30 years.
- The subjects will be males.
- The duration of disease less than 1 year.
Who cannot join
- patients who had skin malignancy in the area to be treated.
- The patients who had history of diabetes, circulatory or sensory disorders.
- Patients with acute infection in the area treated.
Trial locations and contacts
1 site in 1 country.
About this study
Non-atopic dermatitis (NAD) or eczema is a common inflammatory condition; potentially debilitating that can compromise quality of life. It is usually seen in childhood, but can onset within or persist into adulthood.
Read the detailed description
Polarized ultraviolet-free polychromatic light is used as therapeutic option for the treatment of wound healing and dermatological conditions.
40 male patients who had atopic dermatitis in the chronic stage, they were complaining from itching, inflammation and skin thickness in the arm, wrist, hand and leg will participate in this study.
- Conditions
- Chronic Atopic Dermatitis
- Being tested
- polarized light, Topical corticosteroid ointment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polarized lightDevice
A Bioptron light therapy phototherapeutic device (Bioptron AG, Wollerau, Switzerland) with 5 cm treatment diameter (BIOPTRON MedAll®, 480-3400 nm, polarization level of 95%, power density 40 mW/cm2, energy density 2,4 J/cm2 per minute
Topical corticosteroid ointmentDrug
corticosteroid 1 %.
| Study group | Role | What they receive |
|---|---|---|
| polarized light group | group A (20 patients) will receive Polarized light therapy Receives: Device: polarized light | |
| topical corticosteroid group | group B (20 patients) will receive topical corticosteroid therapy Receives: Drug: Topical corticosteroid ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonography
Ultrasound imaging system used to measure the thickness of the skin at the site of scale for both groups
Measured: 1-2 months
Secondary outcomes (1)
SCORAD Score
The SCORAD (Index) is the best validated scoring system in atopic dermatitis, To measure the extent of AD, the rule of nines is applied on a front/back drawing of the patient's inflammatory lesions. The extent can be graded from 0 to 100. The intensity part of the SCORAD consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness. Each item can be graded on a scale from 0 to 3. The subjective items include daily pruritus and sleeplessness. The SCORAD Index formula is: A/5 + 7B/2 + C. In this formula A is defined as the extent (0-100), B is defined as the intensity (0-18) and C is defined as the subjective symptoms (0-20). The maximal score of the SCORAD Index is 103. The objective SCORAD consist of the extent and the intensity items; the formula is A/5 + 7B/2. The maximal objective SCORAD score is 83 (with 10 additional points for severe disfiguring eczema of the face and hands).
Measured: 1-2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start1 Jul 2021
- Primary completion15 Sep 2021
- Study completion15 Jan 2022
Why it stopped: forgotten
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Atopic DermatitisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud H Mohamed, PhD, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955951
- Sponsor's protocol ID
- AhramCUE
- Status last verified
- Oct 2021
- First submitted
- 16 Jun 2021
- Last updated
- 23 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: ultrasonographic skin thickness results will be shared
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Response to Polarized Light Therapy in the Treatment of Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT04955951
- Acronym / sponsor ID
- AhramCUE
- Conditions
- Chronic Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: forgotten
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 9 Jul 2021 (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.
Non-atopic dermatitis (NAD) or eczema is a common inflammatory condition; potentially debilitating that can compromise quality of life. It is usually seen in childhood, but can onset within or persist into adulthood.
Detailed description
Polarized ultraviolet-free polychromatic light is used as therapeutic option for the treatment of wound healing and dermatological conditions.
40 male patients who had atopic dermatitis in the chronic stage, they were complaining from itching, inflammation and skin thickness in the arm, wrist, hand and leg will participate in this study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| polarized light group | – | Device: polarized lightgroup A (20 patients) will receive Polarized light therapy |
| topical corticosteroid group | – | Drug: Topical corticosteroid ointmentgroup B (20 patients) will receive topical corticosteroid therapy |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The Patient will be referred to physical therapy outpatient clinic, faculty of physical therapy, Ahram Canadian University from dermatology out-clinics in Sheikh Zayed Hospital.
Key inclusion criteria (3 listed)
- The patients' ages will ranged from 20 to 30 years.
- The subjects will be males.
- The duration of disease less than 1 year.
Key exclusion criteria (3 listed)
- patients who had skin malignancy in the area to be treated.
- The patients who had history of diabetes, circulatory or sensory disorders.
- Patients with acute infection in the area treated.
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 |
|---|---|---|
| polarized lightA Bioptron light therapy phototherapeutic device (Bioptron AG, Wollerau, Switzerland) with 5 cm treatment diameter (BIOPTRON MedAll®, 480-3400 nm, polarization level of 95%, power density 40 mW/cm2, energy density 2,4 J/cm2 per minute | Device | polarized light group |
| Topical corticosteroid ointmentcorticosteroid 1 %. | Drug | topical corticosteroid group |
Primary outcome
Ultrasonography
Time frame: 1-2 months
Ultrasound imaging system used to measure the thickness of the skin at the site of scale for both groups
1 secondary outcome
SCORAD Score
Time frame: 1-2 months
Results and safety
The study was stopped early (reason given: forgotten). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Individual participant dataSharing planned: Undecided. ultrasonographic skin thickness results will be shared
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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?
An observational study of Chronic Atopic Dermatitis, run by Ahram Canadian 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 3 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: stopped early, as of the sponsor's last update on 23 Aug 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 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 was stopped early (reason given: forgotten). Results are not available in the source record.
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?
Ultrasonography (time frame: 1-2 months). 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 23 Aug 2023.