An Interventional, Prospective, Three-arm Clinical Study to Assess the Safety and Efficacy of Test Treatments in AdulT Patients with Mild to Moderate Atopic Dermatitis Persisting for at Least Six Months
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 55
- 试验地点
- 1
研究概览
简要总结
This is three-arm, placebo controlled, comparative, interventional, prospective, partially-blinded, safety and efficacy study of test treatments in subjects with mild to moderate AD patients.
20 subjects in test treatment A group 20 subjects in test treatment B group, 15 subjects in test treatment C group, aged between 20 to 65 years, with mild to moderate Atopic Dermatitis for at least 6 months, will be enrolled in the study.
Patients will be pre-screened by the screening department of NovoBliss Research. The potential subjects will be screened as per the inclusion & exclusion criteria only after obtaining written informed consent from the subjects. Patients will be contacted telephonically by the recruiting department prior to enrolment visit.
There will be total of 2 visits for test treatment A and test treatment B and total of 4 visits for test treatment C during the study. The duration of the study will be 14 Days (±2 Days) from the enrolment. Subjects will be instructed to visit the facility as per below visits:
Pre-screening: AD was assessed bydermatologist’s and/or Dermatologist’s trained evaluator.
For test treatment A and test treatment B:
Visit 01 (Day 01 ± 2 Days): Screening, Enrolment, Baseline Evaluations, Post Treatment Usage Evaluations
Visit 02 (Day 14 ± 2 Days): Before Test Treatment Evaluations, Treatment Usage and Evaluations
For test treatment C:
Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluations, Post Treatment Usage Evaluations
Visit 02 (Day 05 ± 2 Days): Acupuncturetherapy
Visit 03 (Day 10 ± 2 Days): Acupuncture therapy
Visit 04 (Day 14 ± 2 Days): Before Test Treatment Evaluations, Treatment Usage and Evaluations
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 20 to 65 years at the time of consent.
- •Sex: Male and non-pregnant or non-lactating females.
- •Females of childbearing potential must have a self-reported negative pregnancy test.
- •Subject are generally in good health.
- •Subject’s with mild to moderate Atopic Dermatitis determined by Eczema Area and Severity Index (EASI) score with moderate erythema (redness: score 2) and mild scratch mark (scratching: score 1) will be enrolled into the study 6) Subjects diagnosed with mild to moderate atopic dermatitis of greater than or equal to 6 months’ duration, with at least one active lesion accessible for instrumental measurements.
- •Subjects should not have used any cosmetic, nutraceutical or therapeutic products for atopic dermatitis in last 1 month.
- •Subjects are not allowed to participate in any other study until this study is complete.
- •Subjects willing and able to follow the study directions.
- •Having childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device or injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence).
- •Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
- •Subjects willing to give written informed consent.
- •Subjects willing to use test treatment throughout the study period.
- •Subjects must agree to record each use of the test treatments in the subject’s diary card on daily basis.
- •Subjects must agree to record medication use during the study.
排除标准
- •History of any skin condition other than atopic dermatitis.
- •Subjects who have used any cosmetic, nutraceutical or therapeutic products for skin last one month.
- •History of alcohol or drug addiction.
- •The subject has a known allergy or sensitivity to treatment ingredients.
- •The subject has any other skin conditions i.e. cuts, scratches, ring worms, etc.
- •which in the opinion of the Investigator, will interfere with the study results or will create undue risk for the subject.
- •History of other significant dermatological or systemic diseases that may interfere with study participation or data interpretation.
- •Known neurological or psychiatric disorders that could interfere with EEG assessments.
- •The subject must not have participated in a clinical study within 4 weeks prior to the pre- screening visit of this study.
- •Pregnant or breastfeeding or planning to become pregnant during the study period.
- •History of chronic illness which may influence the cutaneous state.
研究者
Dr Nayan Patel
NovoBliss Research Private Limited