A clinical study to determine the safety and effect of the Test product Tep-AD Daily Lotion in Healthy Human Subjects with light to medium red, itchy and sensitive skin for 8-Weeks Home Use Test
- Registration Number
- CTRI/2022/02/039991
- Lead Sponsor
- Inzpera Healthsciences Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 26
1)� 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.
2)� Sex: Healthy children (male or female) and adults (males and non-pregnant/non-lactating females) with mild to moderate atopic dermatitis.
3)Ã? Subjectââ?¬•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.
4)� Subject is diagnosed with mild to moderate atopic dermatitis with at least 1 active lesion that is accessible for instrumental measurements.
5)� Females of childbearing potential (above 14 years of age to menopause) should have a negative urine pregnancy test at the time of screening visit.
6)� � Subjects (adults and children) are generally in good general health as determind from a recent medical history, except for the atopic dermatitis.
7)� � If subjects (adults and children) are using or taking any presecription or over the counter (OTC) medications prescribed by their physicians, they must be taking the medication for at least 4 weeks.
8)Ã? Ã? Subjectââ?¬•s and childââ?¬•s legal parent or guardian must agree to use the same brands and agree not to switch brands or variants of any skin care products during the study period.
9)Ã? Ã? Subjectââ?¬•s and childââ?¬•s legal parent or guardian must agree to limit the sun exposure to affected areas such as arms, legs covered during prolonged sun exposure.
10)Ã? Subjectââ?¬•s and childââ?¬•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 study duration of 60 days.
11)� � Subjects and Legal parent 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.
12)� Subjects and Legal parent or guardian must avoid allowing subject to swim or play in chlorinated water during study period.
13)� Subjects are not allowed to participate in any other study until this study is complete.
14)Ã? Subjects and childââ?¬•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.
15)Ã? Subjects and Childââ?¬•s legal parent or guardian must be willing to stop using all of the subjectââ?¬•s normal body lotions for the duration of the study (8 weeks) and to use the provided test daily lotion as directed.
16)Ã? Subjects and Childââ?¬•s legal parent or guardian must agree to record each use of the test product in the subjectââ?¬•s diary card on daily basis.
17)Ã? Subjects and Childââ?¬•s legal parent or guardian must agree to record medication use during the study.
18)Ã? Subjectââ?¬•s and childââ?¬•s legal parent or guardian must read, sign, and receive a copy of Informed Consent/Parental Informed Consent prior to initiate of study procedures
1)Ã? The subjectââ?¬•s or Childââ?¬•s legal parent or guardian is an employee of the Sponsor or CRO.
2)� 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.
3)� The subject has a known allergy or sensitivity to soaps, lotions, detergents, detangerls or fragrances.
4)� 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.
5)� The subject has any of the following conditons 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, thiroid or have or had any type of cancer.
6)� 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 dosage or 3 or more days of anti-inflammatories (within 1 week of study enrolment) or anti-histamines.
7)� The subject must not have participated in a clinical study within 4 weeks prior to the screening visit of this study.
8)Ã? Any other condition which could warrant exclusion from the study, as per the dermatologistââ?¬•s/investigatorââ?¬•s discretion.
9)� Pregnant or breastfeeding or planning to become pregnant during the study period.
10)� History of chronic illness which may influence the cutaneous state.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess effect of test product on atopic dermatitis severity on adult and child subjectâ��s affected skin by using SCORAD Index, Eczema Area and Severity Index (EASI)Timepoint: Baseline on Day 1 before use Vs. Day 30 (�±2 days), Day 60 (�±2 days) after use
- Secondary Outcome Measures
Name Time Method