Fractional Carbon Dioxide Laser: A Novel Therapeutic Option for Lichen Simplex Chronicus

February 16, 2024 updated by: Lobna Gamal Alieldin, Cairo University

Fractional Carbon Dioxide Laser: A Novel Therapeutic Option for Lichen Simplex Chronicus: A Randomized Controlled Trial

The goal of this randomized control trial is to compare the use of fractional carbon dioxide (Co2) laser to topical corticosteroids to treat lichen simplex chronicus (LSC) patients presenting to Dermatology outpatient clinic, Faculty of Medicine, Cairo University.

Participants will:

  • Be assessed clinically by doctor
  • Biopsies will be taken from them by doctor
  • Receive treatment as laser or topical steroids or both
  • Fill in depression questionnaire.

Researchers will divide and compare groups as follows:

Sixty patients will be divided randomly through closed envelop technique into 2 groups (Group A and B) each of 30 patients. Group A will be subdivided into 2 groups (1 and 2). All LSC lesions will be treated in any patient having multiple lesions.

  • Group 1 - A: Patients will receive 3 monthly laser sessions, in addition to the use of topical emollients only once daily in between the sessions.
  • Group 2 - A: Patients will receive 3 monthly laser sessions, in addition to topical steroids twice daily and topical emollient once daily in between the sessions.
  • Group B: Patients will be prescribed topical steroids twice daily and topical emollient once daily for 3 months.

to see if:

  1. Pruritus severity scale.
  2. Scaling, erythema, lichenification excoriation scores
  3. Visual analogue scale.
  4. Investigator's Global Assessment.
  5. Itching mediators (Interleukin-31, Nerve Growth Factor and Substance P assays (itching mediators)
  6. Depression

improve more in which group of patients after treatment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

All the patients were subjected to the following:

I. Before treatment:

A. Consent: An informed written consent will be signed by each patient before enrolment in the study.

B. Detailed history taking :

• Personal history: name, age, sex, skin type, occupation, residence, marital status, and smoking.

  • History of present illness: onset, course, duration of disease, precipitating factors and any medications.
  • Past history of any associated systemic or dermatological diseases.
  • Family history of any dermatological disease e.g. psoriasis, atopic dermatitis,….etc.
  • Drug history.

C. Skin biopsy: Two 3 mm punch biopsies will be taken from the lesion from each patient under local anesthesia using (Lidocaine®). One for histopathology to confirm diagnosis of LSC and the other for measuring itching mediators in the lesion before treatment by enzyme-linked immunosorbent assay (ELISA)). Another biopsy will be taken from a non lesional skin from same patient for measuring itching mediators by ELISA. Biopsies for ELISA will be stored at -20 degree celsius in eppendorfs with 3 ml phosphate buffer saline (PBS) added to each eppendorf. Tissue samples with PBS will be homogenized by a grinder, then centrifuged for 20 minutes at 3000 revolutions per minute (rpm) speed, the supernatant will be removed to be added to the ELISA kit wells for Human Interleukin-31, Nerve Growth Factor and Substance P assays (itching mediators)

D. Clinical assessment:

  1. Pruritus severity scale.
  2. Scaling, erythema, lichenification excoriation scores
  3. Visual analogue scale.

  4. Investigator's Global Assessment.

    E. Depression assessment: Beck Depression Inventory questionnaire will be used to assess the depression in each patient .

    F. Therapeutic Intervention: Patients will be divided as discussed before. - Topical steroids used will be a moderate potency topical steroid.

    • Fractional carbon dioxide laser sessions for groups A (1 and 2) by laser machine.
    • Parameters of laser session: (Parameters will be adjusted according to skin type, lesion thickness and condition) Power 15 to 20 watt according to skin color. Dwell time 800 to1000 milliseconds. Spacing 600 micrometers. Stack 2

    II. After treatment:

    A. Assessment of biochemical efficacy (measuring itching mediators after treatment): After one month from the last session for group A and after one month from stoppage of steroids for group B, a skin biopsy from the plaque (from a nearby site to the former one) will be taken as discussed before for ELISA.

    B. Assessment of clinical efficacy by scores as discussed before.

    C. Depression assessment: Beck Depression Inventory questionnaire will be repeated.

    D. Assessment of safety:

    • Assessment of side effects of laser and their treatment:

    Erythema, burning sensation, PIH, pruritus and/or pixilation. • Assessment of side effects of topical corticosteroids and their treatment: Atrophy, telangiectasia, hypopigmentation, hypertrichosis, purpura, ulceration, irritation, secondary infection.

    • Assessment of side effects of skin biopsy and their treatment: Bleeding, secondary infection and/or Scarring.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11562
        • Lobna Alieldin
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lobna Alieldin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with LSC with no underlying dermatological disease, not on topical or systemic treatment for at least 4 weeks prior to study.

Exclusion Criteria:

  • Pregnant and lactating females.
  • Patients who are diagnosed with any systemic disease that can result in generalized pruritus (e.g. hepatic, renal, uncontrolled diabetes mellitus, thyroid,….etc ) from history.
  • Patients with contraindications to laser e.g., keloidal tendency, post inflammatory hyperpigmentation (PIH).
  • Patients with dermatological disease (e.g. psoriasis, atopic dermatitis, ….etc)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Topical Corticosteroids
Patients will be prescribed topical steroids cream twice daily and topical emollient once daily for 3 months.
Drug: Betamethasone Valerate 0.1% Cream
Moderate potency
Drug: Vaseline Topical Product
Emollient
Active Comparator: Fractional carbon dioxide
Patients will receive 3 monthly laser sessions, in addition to the use of topical emollients only once daily in between the sessions.
Drug: Vaseline Topical Product
Emollient
Device: SmartXide® fractional carbon dioxide laser
Ablative
Active Comparator: Combined topical corticosteroids and Laser
Patients will receive 3 monthly laser sessions, in addition to topical steroids twice daily and topical emollient once daily in between the sessions.
Drug: Betamethasone Valerate 0.1% Cream
Moderate potency
Drug: Vaseline Topical Product
Emollient
Device: SmartXide® fractional carbon dioxide laser
Ablative

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison between 2 groups regarding change in Pruritus severity scale
Time Frame: through study completion, an average of 5months
Minimum value: 3 , Maximum value: 22 , higher scores mean a worse outcome.
through study completion, an average of 5months
Comparison between 2 groups regarding change in Visual analogue scale
Time Frame: through study completion, an average of 5months
Minimum value:0 , Maximum value: 10, higher scores mean a worse outcome.
through study completion, an average of 5months
Comparison between 2 groups regarding change in Investigator's Global Assessment.
Time Frame: through study completion, an average of 5months
Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.
through study completion, an average of 5months
Comparison between 2 groups regarding change in Scaling score
Time Frame: through study completion, an average of 5months
Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.
through study completion, an average of 5months
Comparison between 2 groups regarding change in Erythema score
Time Frame: through study completion, an average of 5months
Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.
through study completion, an average of 5months
Comparison between 2 groups regarding change in Lichenification score
Time Frame: through study completion, an average of 5months
Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.
through study completion, an average of 5months
Comparison between 2 groups regarding change in Excoriation score
Time Frame: through study completion, an average of 5months
Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.
through study completion, an average of 5months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of depression score in both groups.
Time Frame: through study completion, an average of 5months
Minimum value: 0, Maximum value: 63, higher scores mean a worse outcome.
through study completion, an average of 5months
change of itching mediators' levels (IL-31, Nerve Growth Factor and substance) between 2 groups
Time Frame: through study completion, an average of 5months
all will be measured by pg/ml
through study completion, an average of 5months
Comparison of itching mediator's levels in lesional, non-lesional skin and healthy controls
Time Frame: through study completion, an average of 5months
all will be measured by pg/ml
through study completion, an average of 5months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 30, 2024

Study Registration Dates

First Submitted

January 19, 2024

First Submitted That Met QC Criteria

February 16, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD-232-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Participants' data that underlie reported results will be shared upon request, after deidentification, for researches who provide a methodologically sound proposal to access data to achieve aims in the approved proposal. This is beginning 3 months up to 12 months after publication.

IPD Sharing Time Frame

3 months up to 12 months after publication.

IPD Sharing Access Criteria

Researches who provide a methodologically sound proposal to access data to achieve aims in the approved proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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