Exploratory Clinical Investigation on Neurosensory Responses via EEG headband in Adults with Mild to Moderate Atopic Dermatitis after Application of marketed product Compared with placebo (water application).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
This is a prospective, exploratory, double-blind, single-visit internal validation study designed to evaluate neurosensory responses using electroencephalography head band (EEG) in adult subjects with mild to moderate atopic dermatitis (AD) following a single topical application of marketed product compared with placebo (water application).
A total of twenty (20) subjects will be enrolled with ten in each arm, aged between 18 to 65 years, with mild to moderate AD for at least six months. Participants will be recruited after providing with the written subject information sheet, and eligibility will be determined based on predefined inclusion and exclusion criteria.
The study consists of a single visit (Day 01), during which participants will undergo screening, randomization, enrolment, and baseline evaluations, followed by product application and post-application assessments up to 30 minutes, after which end-of-study procedures will be completed.
Validation assessments will consist of EEG recordings to evaluate neurosensory responses in subjects with atopic dermatitis. The analysis will focus on changes in alpha, beta, and thetabrainwave activity, which are key indicators of cortical processing related to sensory perception. In addition to EEG, digital photographs will be captured using a Nikon D3300 camera to document any visible skin changes, if any.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 18 to 65 years (both inclusive) at the time of consent having mild to moderate atopic dermatitis.
- •Sex: Healthy male and non-pregnant/non-lactating females.
- •Females of childbearing potential must have a self-reported negative pregnancy test.
- •Subject are generally in good health.
- •Subjects who agree to come to the facility with clean and dry scalp and hair 6) Subjects 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 7) 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/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 consent through subject information sheet.
- •Subjects have not participated in a similar investigation in the past three months.
- •Subjects willing to use test product throughout the study period.
排除标准
- •History of any dermatological condition of the skin diseases.
- •Subject with present condition of allergic response to any cosmetic product.
- •Subjects with other dermatologic diseases besides AD whose presence or treatments could interfere with the assessment of disease (eg, Psoriasis).
- •Subjects who used systemic immunosuppressants within 4 weeks, topical steroids or immunomodulators within 1 week, moisturizers within 12 hours before evaluation.
- •History of alcohol or drug addiction.
- •The subject has a known allergy or sensitivity to soaps, lotions, detergents, detanglers or fragrances.
- •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.
- •Subjects having diabetes, hepatitis, epilepsy, thyroid or have or had any kind of cancer.
- •The subject must not have participated in a clinical study within 4 weeks prior to the screening visit of this study.
- •Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
- •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 Pvt Ltd