Ignite Creation Date:
2025-12-25 @ 4:45 AM
Ignite Modification Date:
2025-12-26 @ 3:47 AM
Study NCT ID:
NCT06489418
Status:
COMPLETED
Last Update Posted:
2025-03-03
First Post:
2024-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Study to Assess the Safety and Effectiveness of Test Product in Healthy Adult Human Subjects With Dry and Sensitive Skin.
Sponsor:
NovoBliss Research Pvt Ltd
Organization:
Study Overview
Official Title:
A Prospective, Control-arm, Site Randomized, Evaluator-blinded, Single-centre, Safety, and Efficacy Study of Test Product "Dew Restore Barrier Repair Cream" in Healthy Adult Human Subjects With Dry and Sensitive Skin.
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A prospective, control-arm, site randomized, evaluator-blinded, single-centre, safety, and efficacy study of Test Product "Dew Restore Barrier Repair Cream" in healthy adult human subjects with dry and sensitive skin.
Detailed Description:
A total of 27 Subjects will be enrolled to complete 25 Subjects the study. The potential subjects will be screened as per the inclusion \& exclusion criteria only after obtaining written informed consent from the subjects. Subjects will be pre-screened by the screening department of NovoBliss Research. Subjects will be called telephonically by the recruiting department prior to the enrolment visit. Subjects will be told during screening (prior to enrolment) not to wear any facial make-up on the study visit day. The adult female subjects will be instructed to visit the facility as per the below visits.
* Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluation, On Site Product Usage, Post Usage Evaluation
* Visit 02 (Day 02): Evaluations, Product usage period
* Visit 03 (Day 15 +2 Days): Product Usage Period, Evaluations
* Visit 04 (Day 30 +2 Days): Evaluations, End of Study
* Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluation, On Site Product Usage, Post Usage Evaluation
* Visit 02 (Day 02): Evaluations, Product usage period
* Visit 03 (Day 15 +2 Days): Product Usage Period, Evaluations
* Visit 04 (Day 30 +2 Days): Evaluations, End of Study
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: