Ultrasonographic Response to Polarized Light Therapy in the Treatment of Atopic Dermatitis

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Atopic Dermatitis
• Intervention / Treatment: Device: polarized light; Drug: Topical corticosteroid ointment

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 Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Ahram Canadian University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

• The patients' ages will ranged from 20 to 30 years.
• The subjects will be males.
• The duration of disease less than 1 year.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
polarized light group; group A (20 patients) will receive Polarized light therapy	Device: polarized light; 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 group; group B (20 patients) will receive topical corticosteroid therapy	Drug: Topical corticosteroid ointment; corticosteroid 1 %.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasonography	Ultrasound imaging system used to measure the thickness of the skin at the site of scale for both groups	1-2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1-2 months

Collaborators and Investigators

• Sponsor: Ahram Canadian University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): September 15, 2021
• Study Completion (Actual): January 15, 2022

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 9, 2021

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 20, 2023
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: AhramCUE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: ultrasonographic skin thickness results will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No