Fractional Carbon Dioxide Laser: A Novel Therapeutic Option for Lichen Simplex Chronicus: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Comparison between 2 groups regarding change in Pruritus severity scale
研究概览
简要总结
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:
- Pruritus severity scale.
- Scaling, erythema, lichenification excoriation scores
- Visual analogue scale.
- Investigator's Global Assessment.
- Itching mediators (Interleukin-31, Nerve Growth Factor and Substance P assays (itching mediators)
- Depression
improve more in which group of patients after treatment.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Experienced dermatologist blinded to the interventions done will assess the patients' at the end of the treatment period.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with LSC with no underlying dermatological disease, not on topical or systemic treatment for at least 4 weeks prior to study.
排除标准
- •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)
研究组 & 干预措施
Topical Corticosteroids
Patients will be prescribed topical steroids cream twice daily and topical emollient once daily for 3 months.
干预措施: Vaseline Topical Product (Drug)
Topical Corticosteroids
Patients will be prescribed topical steroids cream twice daily and topical emollient once daily for 3 months.
干预措施: Betamethasone Valerate 0.1% Cream (Drug)
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.
干预措施: SmartXide® fractional carbon dioxide laser (Device)
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.
干预措施: Vaseline Topical Product (Drug)
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.
干预措施: Betamethasone Valerate 0.1% Cream (Drug)
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.
干预措施: SmartXide® fractional carbon dioxide laser (Device)
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.
干预措施: Vaseline Topical Product (Drug)
结局指标
主要结局
Comparison between 2 groups regarding change in Pruritus severity scale
时间窗: through study completion, an average of 5months
Minimum value: 3 , Maximum value: 22 , higher scores mean a worse outcome.
Comparison between 2 groups regarding change in Visual analogue scale
时间窗: through study completion, an average of 5months
Minimum value:0 , Maximum value: 10, higher scores mean a worse outcome.
Comparison between 2 groups regarding change in Investigator's Global Assessment.
时间窗: through study completion, an average of 5months
Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.
Comparison between 2 groups regarding change in Scaling score
时间窗: through study completion, an average of 5months
Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.
Comparison between 2 groups regarding change in Erythema score
时间窗: through study completion, an average of 5months
Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.
Comparison between 2 groups regarding change in Lichenification score
时间窗: through study completion, an average of 5months
Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.
Comparison between 2 groups regarding change in Excoriation score
时间窗: through study completion, an average of 5months
Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.
次要结局
- change of depression score in both groups.(through study completion, an average of 5months)
- change of itching mediators' levels (IL-31, Nerve Growth Factor and substance) between 2 groups(through study completion, an average of 5months)
- Comparison of itching mediator's levels in lesional, non-lesional skin and healthy controls(through study completion, an average of 5months)
研究者
Lobna Gamal Alieldin
Assistant lecturer
Cairo University