Investigator-Initiated, Randomized, Investigator-Blind, Half-Side Comparison of Topical Oregano Extract Ointment vs .Hydrocortisone 1% for the Treatment of Atopic Dermatitis in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- The Clinical Efficacy Rated by the Patient or Caregiver on Days 0 and 25
研究概览
简要总结
This study is designed to evaluate and compare the efficacy of 3% oregano extract ointment prepared in aqueous solution versus 1% hydrocortisone ointment, a standard treatment, in decreasing the inflammation associated with mild to moderate atopic dermatitis. We plan to recruit 40 patients on the ages comprised between 2 and 17 years old and the study duration for each of the patient is 1 month.
详细描述
A single-center, investigator initiated, randomized controlled, double-blind trial will be conducted to determine the effects of an oregano extract in aqueous solution versus 1% hydrocortisone in the treatment of acute-subacute pediatric atopic dermatitis (AD). We suspect that topical oregano will serve as an effective, non-steroidal AD therapy, simultaneously offering extra benefits to pediatric patients as oregano is a natural product with antimicrobial, anti-inflammatory, and antiseptic properties that lacks reports of adverse effects associated with steroids, which children have been noted to be more susceptible to.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant female subjects aged 2-17 years of age.
- •Individuals must be diagnosed with acute-subacute AD regardless of the study.
- •Written informed consent must be obtained from all patients or caregivers.
- •Women of childbearing potential (WOCBP) must be willing to practice effective contraception for the duration of study treatment.
- •Subjects must be willing and able to comply with study conditions, properly apply or have caregivers apply topical medications to the selected body sites, as well as return to the clinic for required visits.
- •Subject caregivers must be willing and able to perform ADQ assessment test.
排除标准
- •Individuals who are immune-compromised or suffering from infectious disease, malignant disease, are known to be HIV+ or present with a general reduced level of health.
- •Individuals diagnosed with underlying dermatological conditions in addition to AD.
- •Individuals with a chronic pre-existing disease such as diabetes mellitus or others that in the opinion of the investigator would preclude their participation in the study.
- •Individuals who are pregnant, nursing mothers, or subjects planning a pregnancy during the course of the study.
- •Subjects/caregivers who are unable to communicate or comply with study conditions due to language disability, poor mental development, or impaired cerebral function.
- •Individuals who are simultaneously enrolled in another clinical drug or device research study.
- •Individuals with a history of chronic steroid use.
- •Individuals needing to concurrently use topical agents, medicinal products containing corticosteroids, or immunosuppressants.
- •Individuals who have received systemically administered corticosteroids and/or antihistamines 2 weeks prior to the start of study.
- •Individuals undergoing light therapy.
- •Individuals who have been treated with another investigation device or drug within 30 days prior to study enrollment.
- •Individuals with a known allergy to oregano.
研究组 & 干预措施
Standard: Hydrocortisone 1% ointment
Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm
干预措施: Hydrocortisone (Drug)
Experimental: oregano extract cream
Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm
干预措施: Oregano extract cream (Drug)
结局指标
主要结局
The Clinical Efficacy Rated by the Patient or Caregiver on Days 0 and 25
时间窗: From baseline to day 25
This was measured with two questions. The first one referred to the description of the lesion and it included six characteristics: clear, dry, scaly, redness, cracks/opening and oozing. The second questions asked to grade how itchy was the patient. All characteristics were measured on a scale from 0 to 5 (0 none, 5 extremely bothered/losing sleep).
Change of the Clinical Efficacy Rated by a Study Physician
时间窗: Baseline to day 28
Physician was asked to grade four characteristics: erythema, infiltration/papulation, excoriation and lichenification. The grade was none (0), mild (1), moderate (2) and severe (3).
Histological Improvement Measured by Confocal Microscopy
时间窗: Baseline to day 28
Confocal microscopy was done to the patient on day 0, day 14 and day 28. Due to technical difficulties, this outcome measure was not collected.
次要结局
- Measure Presence of S. Aureus Colonization on Affected Skin(Baseline to day 14)
- Rate Cosmetic Acceptability of Topical Agents(On day 7 and 14)
- Rate Skin Tolerance of Topical Agents(On day 7 and 14)