Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-01-01 @ 5:20 AM
Study NCT ID:
NCT07111156
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-08
First Post:
2025-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study to Test the Safety and Effectiveness of Pinorox® for Improving Visible Signs of Facial Aging Such as Wrinkles, Fine Lines, and Dark Spots.
Sponsor:
NovoBliss Research Pvt Ltd
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Three-Arm, Prospective, Single-Center Clinical Study to Evaluate the Safety, Efficacy, and Tolerability of Pinorox® in Subjects With Facial Signs of Aging
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
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 Randomized, Double-Blind, Three-Arm, Prospective, Single-Center Clinical Study to Evaluate the Safety, Efficacy, and Tolerability of Pinorox® in Subjects with Facial Signs of Aging
Detailed Description:
This is a randomized, double-Blind, three-arm, prospective, single-centre clinical study to evaluate the safety, efficacy, and tolerability of pinorox® in subjects with facial signs of aging. A total of 81 subjects (27 subjects/treatment) will be enrolled in the study, comprising male and non-pregnant, non-lactating female participants aged 35 to 55 years (inclusive). Subjects must present with visible Crow's feet wrinkles, fine lines, and facial dark spots at baseline. Participants will be equally distributed across three treatment groups with 27 subjects per group.
The study is designed to complete with at least 75 evaluable subjects (25 per treatment group), accounting for potential dropouts or withdrawals during the study period.
The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining the written informed consent from the study participants. Subjects will be contacted telephonically by recruiting department prior the enrolment visit.
There will be total of 3 visits during the study. The duration of the study will be 60 Days (8 weeks) from the enrolment. Subjects will be instructed to visit the facility as per below visits.
Visit: 01 (Day 01, Week 00): Screening, ICD obtained, Enrolment, Baseline readings and post product usage readings.Visit 02 (Day 30, Week 04): Treatment Phase, Evaluations Visit 03 (Day 60, Week 08): Evaluations and Treatment Phase end \| End of Study
The study is designed to complete with at least 75 evaluable subjects (25 per treatment group), accounting for potential dropouts or withdrawals during the study period.
The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining the written informed consent from the study participants. Subjects will be contacted telephonically by recruiting department prior the enrolment visit.
There will be total of 3 visits during the study. The duration of the study will be 60 Days (8 weeks) from the enrolment. Subjects will be instructed to visit the facility as per below visits.
Visit: 01 (Day 01, Week 00): Screening, ICD obtained, Enrolment, Baseline readings and post product usage readings.Visit 02 (Day 30, Week 04): Treatment Phase, Evaluations Visit 03 (Day 60, Week 08): Evaluations and Treatment Phase end \| 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?: