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

NCT06267066 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-02-20

No results posted yet for this study

Summary

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.

Conditions

  • Lichen Simplex Chronicus

Interventions

DRUG

Betamethasone Valerate 0.1% Cream

Moderate potency

DEVICE

SmartXide® fractional carbon dioxide laser

Ablative

DRUG

Vaseline Topical Product

Emollient

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2024-08-01
Completion
2024-08-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06267066 on ClinicalTrials.gov