An interventional study of Betamethasone Valerate 0.1% Cream and SmartXide® fractional carbon dioxide laser in Lichen Simplex Chronicus, sponsored by Cairo University. Not yet recruiting at 2 sites in Egypt. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-20.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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:
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.
to see if:
improve more in which group of patients after treatment.
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 :
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:
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.
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:
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.
22 studies on the registry are indexed under Neurodermatitis; 3 are open to participants now.
This study's planned enrollment of 60 is above the median of 44 across 22 interventional studies indexed under Neurodermatitis.
Browse Neurodermatitis studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will be prescribed topical steroids cream twice daily and topical emollient once daily for 3 months.
Drug: Betamethasone Valerate 0.1% Cream · Drug: Vaseline Topical Product
Patients will receive 3 monthly laser sessions, in addition to the use of topical emollients only once daily in between the sessions.
Device: SmartXide® fractional carbon dioxide laser · Drug: Vaseline Topical Product
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 · Device: SmartXide® fractional carbon dioxide laser · Drug: Vaseline Topical Product
Moderate potency
Ablative
Emollient
Comparison between 2 groups regarding change in Pruritus severity scale
Minimum value: 3 , Maximum value: 22 , higher scores mean a worse outcome.
Time frame: through study completion, an average of 5months
Comparison between 2 groups regarding change in Visual analogue scale
Minimum value:0 , Maximum value: 10, higher scores mean a worse outcome.
Time frame: through study completion, an average of 5months
Comparison between 2 groups regarding change in Investigator's Global Assessment.
Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.
Time frame: through study completion, an average of 5months
Comparison between 2 groups regarding change in Scaling score
Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.
Time frame: through study completion, an average of 5months
Comparison between 2 groups regarding change in Erythema score
Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.
Time frame: through study completion, an average of 5months
Comparison between 2 groups regarding change in Lichenification score
Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.
Time frame: through study completion, an average of 5months
Comparison between 2 groups regarding change in Excoriation score
Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.
Time frame: through study completion, an average of 5months
change of depression score in both groups.
Minimum value: 0, Maximum value: 63, higher scores mean a worse outcome.
Time frame: through study completion, an average of 5months
change of itching mediators' levels (IL-31, Nerve Growth Factor and substance) between 2 groups
all will be measured by pg/ml
Time frame: through study completion, an average of 5months
Comparison of itching mediator's levels in lesional, non-lesional skin and healthy controls
all will be measured by pg/ml
Time frame: through study completion, an average of 5months
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: 3 months up to 12 months after publication.
Access criteria: Researches who provide a methodologically sound proposal to access data to achieve aims in the approved proposal.
No publications or documents are linked to this record.
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Studies of the drug tested here: Betamethasone Valerate