A Synergy, Safety, Efficacy, Skin Compatibility Study of SkidelBar, Skidel Foam and TEP-AD Daily Lotion in Healthy HumanSubjects with Mild to Moderate Atopic Dermatitis in 8-WeeksHome Use Test.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- adult and child subject’s affected skin by using SCORAD Index, Eczema Area and Severity Index
研究概览
简要总结
This is a double-blind, four-arm, four treatment, single-centre, synergy, safety and efficacy, a skin compatibility clinical study of ‘Skidel Bar, Skidel Foam and Tep-AD Daily Lotion’ in Healthy Human Subjects with mild to moderate Atopic Dermatitis with at least 1 active lesion at the time of study
enrollment in 8-Weeks Home Use Test. Complete double-blind is not possible considering test treatment Bar and Foam, however, double-blinding will be kept for Daily Lotion with probiotics and without probiotics. A sufficient number (maximum of 64) of male and female adults subjects, children/teenager subjects with a legal parent or legal guardian approval will be recruited to ensure a total of 15 subjects/arm complete the study. Qualifying siblings and family members within the same household are permitted in the study. The Dermatologist’s trained evaluator/physician will determine the subject eligibility and conduct a clinical evaluation of the SCORAD and Eczema Area and Severity Index (EASI) and general skin condition and select at least one (1) lesion site of the subject and final eligibility will be verified by the Dermatologist for subject enrolment. The selected sites (lesion and non-lesion) will be marked on a body map for easy return to the same site at subsequent study visits. The dermatologist’s trained evaluator will also select a single unaffected (non-lesion) site (3 cm * 3 cm), at least 5 centimetres from the nearest affected site, for instrumental hydration assessments. Digital photographs will be taken of the targeted region to confirm the evaluation done by a trained evaluator from the Dermatologist.
Before entering the facility, at security check-post, the subject and/or the subject’s with legal parent/legal guardian will be asked for a pre-entry inquiry check for COVID-19 exposure and symptoms. The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent and/or assent from the subjects and the subjects legal parent/legal guardian.
The adult subject and child’s legal parent/legal guardian will be instructed to visit the facility with their child as per the below visits:
• Visit 01: Screening Visit and Enrolment on Day 01
• Visit 02: Treatment Phase Day 30 (Å}2 Days)
• Visit 03: Treatment Phase & End of the Study Day 60 (Å}2 Days)
Adult subjects and Children’s legal parents/legal guardians will be provided with the subject diary to complete every day. In screening visit mild to moderate atopic dermatitis skin will be determined using SCORAD and Eczema Area and Severity Index (EASI) my dermatologist’s trained evaluator/Investigator will be enrolled on the study.
During the study, visual analogue scale (VAS) for improvement in itching, SCORAD, Eczema area and severity Index, skin hydration using MoistureMeterEpid or equivalent instrument, skin barrier function i.e. Transepidermal water loss (TEWL) using Vapometer or equivalent instrument, Skin swab for S. Aureus counting will be performed before and after application at each time points. Skin swab analysis and subjects self-Assessment questionnaire for product perception will be done on days 30 and 60.
During the 8 week study, subjects and legal parents/guardians are asked to replace the subject’s regular cleaning soap/foam, body lotion with the provided test treatment (Skidel Bar/Foam and body lotion for their moisturization and cleansing needs. Subjects & Parents /guardians will be asked to use the provided cleaning Skidel Bar or Foam and body lotion as they normally would use a body lotion, bar, shampoo, foam on the subjects.
The test treatment cleaning Skidel Bar/foam and Tep-AD daily lotion, are cleared for a market by Inzpera Health sciences, which are hypoallergenic and have passed a Human Repeated Insult Patch testing (HRIPT) done by Inzpera Health sciences. The expected study duration of this study will be a maximum of 62 days (60 Days trial duration +2 Days of window period) from enrolment.
Subjects and Legal parents/guardians should continue to apply the subject’s medical (prescription and/or over the counter (OTC) treatments if the treatments have been prescribed by a physician. Subjects, Legal parents or guardians may apply normal skincare products on the subject’s face or hands, including sunscreens and medication and use normal hair products, i.e. shampoos, conditioners, detanglers. Subjects, legal parents/guardians are asked not to change brands or variants of these products during the study period.
Evaluations will be conducted at screening i.e. week 0 baseline, week 4 and week 8-time points. The dermatologist’s trained evaluator will provide a consensus score for all attributes needed for the calculation of SCORAD, EASI. Skin conductance and capacitance will be clinically measured at the selected lesional and non-lesional sites taking instrumental readings. Subjects and Children’s legal parents and guardians will be asked to complete a quality of life questionnaire, at home before the baseline visit. These questions about their symptoms and activity limitations and behaviours will be asked to complete a few question questionnaires about their perception of the skin condition of lesions sites (area of atopic dermatitis) selected by the study doctors, these questionnaires will be administered at baseline and during the Day 30 (week 4) and Day 60 (week 8) study visits. Skin swab will be collected from the selected single (1) lesion site to see the change in microbial (S. Aureus) growth from baseline on Day 1 before application of test product to Day 30 and Day 60 counts after test product use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: For children: 2 to 17 years (both inclusive) at the time of parental consent/assent and For Adults: 18 to 65 years (both inclusive) at the time of consent.
- •Sex: Healthy children (male or female) and adults (males and non-pregnant/non-lactating females) with mild to moderate atopic dermatitis.
- •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.
- •Subject is diagnosed with mild to moderate atopic dermatitis with at least 1 active lesion that is accessible for instrumental measurements.
- •Females of childbearing potential (above 14 years of age to menopause) should have a a negative urine pregnancy test at the time of screening visit.
- •Subjects (adults and children) are generally in good general health as determined from a recent medical history, except for atopic dermatitis.
- •If subjects (adults and children) are using or taking any prescription or over the counter (OTC) medications prescribed by their physicians, they must be taking the medication for at least 4 weeks.
- •Subject’s and child’s legal parent or guardian must agree to use the same brands and agree not to switch brands or variants of any skincare products during the study period.
- •Subject’s and child’s legal parent or guardian must agree to limit the sun exposure to affected areas such as arms, legs covered during prolonged sun exposure.
- •Subject’s and child’s legal parent or guardian must agree to dress the subjects in loose clothing to allow easy exposure to the entire body during study visits and throughout the study duration of 60 days.
- •Subjects and Legal parents or guardian must avoid allowing the subject a hot or cold beverages within one hour of their scheduled visits and for the duration of all clinic visits, warm beverages are allowed.
- •Subjects are not allowed to participate in any other study until this study is complete.
- •Subjects and child’s legal parent or guardian must be willing and able to follow the study directions and to return for all specified visits with the subject.
- •Subjects and Child’s legal parent or guardian must be willing to stop using all of the subject’s normal cleansing agents i.e. soap/foams, body cleansing milk and moisturizing body lotions for the duration of the study (8 weeks) and to use the provided test treatment Bar/Foam and daily lotion as directed.
- •Subjects and Child’s legal parent or guardian must agree to record medication use during the study.
- •Subject’s and child’s legal parent or guardian must read, sign, and receive a copy of Informed Consent/Parental Informed Consent prior to initiate of study procedures.
排除标准
- •The subject’s or Child’s legal parent or guardian is an employee of the Sponsor or CRO.
- •Change in current prescriptions (within 4 weeks of screening) or new and/or additional prescriptions for the skin condition (within 4 weeks of screening) or during the study.
- •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, ringworms, etc.
- •which in the opinion of the Investigator, will interfere with the study results or will create undue risk for the subject.
- •The subject has any of the following conditions or factors that the Investigator believes may affect the response of the skin or the interpretation of the test results, including, but not limited to diabetes, hepatic conditions, epilepsy, thyroid or have or had any type of cancer.
- •The subject is currently taking or has taken any medication, which the Investigator believes may influence the interpretation of the data, such as 3 or more dosages or 3 or more days of anti-inflammatories (within 1 week of study enrolment) or anti-histamines.
- •The subject must not have participated in a clinical study within 4 weeks prior to the 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.
结局指标
主要结局
adult and child subject’s affected skin by using SCORAD Index, Eczema Area and Severity Index
时间窗: Change from baseline i.e. Day 01 before use to Day 30 (±2 days) and Day 60 (±2 days) after product usage by Dermatologist/Dermatologist’s Trained Evaluator
To assess the synergic effects of test treatment(s) (Skidel Bar and Skidel Foam when its
时间窗: Change from baseline i.e. Day 01 before use to Day 30 (±2 days) and Day 60 (±2 days) after product usage by Dermatologist/Dermatologist’s Trained Evaluator
given with Tep-AD Daily lotion with and without parabiotics) on atopic dermatitis severity on
时间窗: Change from baseline i.e. Day 01 before use to Day 30 (±2 days) and Day 60 (±2 days) after product usage by Dermatologist/Dermatologist’s Trained Evaluator
(EASI)
时间窗: Change from baseline i.e. Day 01 before use to Day 30 (±2 days) and Day 60 (±2 days) after product usage by Dermatologist/Dermatologist’s Trained Evaluator
次要结局
- To assess the synergic effect of test treatment(s) (i.e. Skidel Bar and Skidel Foam when its given with Tep-AD Daily lotion with and without parabiotics) in terms of change in Staphylococcus aureus (S. Aureus) growth using skin swab analysis of lesion areas by conventional culture method - with manual colony counting.(Change from baseline on Day 1 before use Vs. Day 30 (±2)
- To assess the synergic effect of the test treatment(s) [i.e. Skidel Bar and Skidel Foam when its given with Tep-AD Daily lotion with and without parabiotics] in terms of improvement/change in itching using Visual Analogue scale (VAS).(Change from baseline on Day 1 before use Vs. Day 30 (±2 days), Day 60 (±2 days) after use)
- To assess the synergeic effect of the test treatment(s) [i.e. Skidel Bar and Skidel Foam when its given with Tep-AD Daily lotion with and without parabiotics] in terms of skin hydration on (lesional and non-lesional sites) using MoistureMeterEpiD(Change from baseline on Day 1 before use to Day 30 (±2 days), Day 60 (±2 days) after use of test product)
- To assess the synergeic effect of the test treatment(s) [i.e. Skidel Bar and Skidel Foam when its(given with Tep-AD Daily lotion with and without parabiotics] in terms of improvement in skin)
- To assess adult subject’s/child’s experience on fast relief from rash, provide quick wound heal, moisturization, redness, swelling, itching, urticaria, smooth & gentle on adult’s/child’s skin by Quality of Life (QoL) subjective self-assessment questionnaires for adults & parental/guardian questionnaires in terms of product(s) perception(On Day 30 (±2 Days) and Day 60 (±2 Days) after use of test treatment(s))