Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06267066
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-01-19
Brief Title:
Fractional Carbon Dioxide Laser A Novel Therapeutic Option for Lichen Simplex Chronicus
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Fractional Carbon Dioxide Laser A Novel Therapeutic Option for Lichen Simplex Chronicus A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Investigators 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
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 Investigators 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
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 eg psoriasis atopic dermatitisetc
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 Investigators 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 andor 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 andor Scarring
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 eg psoriasis atopic dermatitisetc
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 Investigators 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 andor 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 andor Scarring
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None