To check Safety, Tolerability and effectiveness of HBWW-052005
- Conditions
- Healthy subjects in the age group as below (inclusive of both genders) ≥18-≤45 years, ≥ 2 - -≤12 years, 0 months – -≤2 years, Premature babies (babies born before 37 weeks)
- Registration Number
- CTRI/2023/02/049841
- Lead Sponsor
- Himalaya Wellness Company
- Brief Summary
Study Objective: An open label clinical study to evaluate the Safety, Tolerability and In-use efficacy of HBWW-052005.
Study Design : An open label, sequential, 4 groups clinical safety and efficacy study. Study enrollment will be sequential following the groups.
Both male and female subject -
Group 1: 18-45 years
Group 2: 2 -12 years
Group 3: 0 months – 2 years
Group 4: Premature babies
Study Methodology: All eligible subjects will be enrolled into the study after informed consent procedure. Subject/ Parents of the baby will be provided with the informed consent document and explained about the study in detail. Post informed consent process the baseline assessments will be completed.
The subjects will then be provided with a test product and the subject’s mother will be instructed to use cream baby bar by the Investigator /study coordinator.
Every subject will undergo the visits as scheduled per group. Group 1 and group 2 will have day 1 as screening/ baseline visit investigator assessment scale and at day 3 visit investigator assessment scale, subjective questionnaire assessment and local intolerance will be evaluated.
Group 3 and group 4, at day 1 as screening/ baseline visit investigator assessment scale will be done. At day 7 and day 28 investigator assessment scale, subjective questionnaire assessment and local intolerance will be evaluated. Day 7 will be telephonic visit for group 4 only subjective assessment and local intolerance will be asked during the telephonic visit.
In the presence of the investigator the instructions will be given to use the test product at home.
Study Duration: This study is planned for 03 days for group I and Group II, 28 days for Group III and Group IV.
Number of subjects: 81 evaluable subjects
Direction to Use: Pull out one wipe & gently clean the baby. Carefully reseal the pack flap to keep wipes fresh and moist for the future.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 81
- 1.Healthy subjects in the age group as below (inclusive of both genders) a.Group 1: ≥18-≤45 years (both inclusive) b.Group 2: ≥ 2.
- ≤12 years (both inclusive) c.Group 3: 0 months – -≤2 years (both inclusive) d.Group 4: Premature babies (babies born before 37 weeks) 2.Healthy day 1 babies not requiring medical attention. 3.Babies with signs of atopic dermatitis (dry skin, itchy skin, redness, sensitive skin, rashes) who does not require medical/systemic treatment to be included. Included in group 2 (6 subjects) and group 3 (15 subjects) with signs of atopic dermatitis. 4.Subjects in general good health as determined from a recent medical history. 5.Subjects mother/legal representative, preferably mother willing to give a voluntary written informed consent and agree to come for regular follow up. 6.Subjects mother/legal representative, preferably mother willing to abide by and comply with the study protocol. 7.Subjects should not participate in any other clinical study during participation in the current study.
- 1.A known history or present condition of allergic response to any other concern that may require medical attention.
- 2.Chronic illness which may influence the cutaneous state.
- 3.Subjects not willing to stop the use of other baby powders during the study period.
- 4.Subjects participated in any other clinical study past 4 weeks 5.To determine the experience of test product on baby skin through subjective questionnaires on cleaning as pure as water, gentle cleansing without making skin dry for new-born skin, Suitable/ safe for newborn skin, suitable for sensitive skin babies, safe for use from day 1 of the baby, suitable/ safe for premature baby.
- keeps skin refreshed, keeps baby skin soft and smooth, mildness and gentleness tested in babies and safe on new-born 6.Local tolerance evaluation by the investigator.
- 7.Monitoring of AEs and SAEs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the skin mildness, gentleness and irritability on skin by the investigator. 1. 2 - 12 years Day 01 and Day 03 | 2. 18 - 45 years: Day 01 and Day 03 | 3. 0 - 2 Years: Day1, Day 7, Day 28 | 4. Premature babies: Day1, Day 7, Day 28
- Secondary Outcome Measures
Name Time Method To evaluate the product safety of skin by local intolerance evaluation by investigator 2 - 12 years, 18 - 45 years: Day 03 To determine the experience of test product on baby skin through subjective questionnaires 2 - 12 years, 18 - 45 years: Day 03
Trial Locations
- Locations (2)
Ashirwad Children Hospital, Vaccination Centre & Dental Care
🇮🇳Ahmadabad, GUJARAT, India
NovoBliss Research Pvt. Limited
🇮🇳Ahmadabad, GUJARAT, India
Ashirwad Children Hospital, Vaccination Centre & Dental Care🇮🇳Ahmadabad, GUJARAT, IndiaDr Nirav PatelPrincipal investigator79-48983895consultant@novobliss.in