Lichen Simplex Chronicus Clinical Trial
Official title:
Fractional Carbon Dioxide Laser: A Novel Therapeutic Option for Lichen Simplex Chronicus: A Randomized Controlled Trial
Verified date | February 2024 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | August 30, 2024 |
Est. primary completion date | August 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Egypt | Lobna Alieldin | Cairo | |
Egypt | Lobna Alieldin | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison between 2 groups regarding change in Pruritus severity scale | Minimum value: 3 , Maximum value: 22 , higher scores mean a worse outcome. | through study completion, an average of 5months | |
Primary | Comparison between 2 groups regarding change in Visual analogue scale | Minimum value:0 , Maximum value: 10, higher scores mean a worse outcome. | through study completion, an average of 5months | |
Primary | Comparison between 2 groups regarding change in Investigator's Global Assessment. | Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome. | through study completion, an average of 5months | |
Primary | Comparison between 2 groups regarding change in Scaling score | Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome. | through study completion, an average of 5months | |
Primary | Comparison between 2 groups regarding change in Erythema score | Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome. | through study completion, an average of 5months | |
Primary | Comparison between 2 groups regarding change in Lichenification score | Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome. | through study completion, an average of 5months | |
Primary | Comparison between 2 groups regarding change in Excoriation score | Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome. | through study completion, an average of 5months | |
Secondary | change of depression score in both groups. | Minimum value: 0, Maximum value: 63, higher scores mean a worse outcome. | through study completion, an average of 5months | |
Secondary | change of itching mediators' levels (IL-31, Nerve Growth Factor and substance) between 2 groups | all will be measured by pg/ml | through study completion, an average of 5months | |
Secondary | Comparison of itching mediator's levels in lesional, non-lesional skin and healthy controls | all will be measured by pg/ml | through study completion, an average of 5months |
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