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

Sponsor
Ahram Canadian University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04955951
Collaborator
(none)
40
1
3.5
11.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
40 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Ultrasonographic Response to Polarized Light Therapy in the Treatment of Atopic Dermatitis
Actual Study Start Date :
Jul 1, 2021
Actual Primary Completion Date :
Sep 15, 2021
Anticipated Study Completion Date :
Oct 15, 2021

Arms and Interventions

Arm 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 MedAllĀ®, 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 %.

Outcome Measures

Primary Outcome Measures

  1. Ultrasonography [1-2 months]

    Ultrasound imaging system used to measure the thickness of the skin at the site of scale for both groups

Secondary Outcome Measures

  1. SCORAD Score [1-2 months]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 30 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ahram Canadian University Giza Egypt

Sponsors and Collaborators

  • Ahram Canadian University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mahmoud H Mohamed, PhD, LECTURER, Ahram Canadian University
ClinicalTrials.gov Identifier:
NCT04955951
Other Study ID Numbers:
  • AhramCUE
First Posted:
Jul 9, 2021
Last Update Posted:
Oct 12, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 12, 2021