Ignite Creation Date:
2025-12-18 @ 9:28 AM
Ignite Modification Date:
2025-12-23 @ 5:46 PM
Study NCT ID:
NCT05499247
Status:
None
Last Update Posted:
2022-09-29 00:00:00
First Post:
2022-08-03 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Proof-of-Concept, Safety and Efficacy Study of SkinQ Glow Bright Wonder Mask in Healthy Human Subjects
Sponsor:
None
Organization:
Study Overview
Official Title:
A Proof-of-Concept, Safety and Efficacy Study of SkinQ Glow Bright Wonder Mask in Healthy Human Subjects and With Adequate Representation of Varied Skin Types (Normal, Oily, Dry, Combined, and Sensitive Skin)
Status:
None
Status Verified Date:
2022-09
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:
The potential subjects will be screened as per the inclusion \& exclusion criteria only after obtaining written informed consent from the subjects. This is a single-day, single-visit study.
Subjects will be pre-screened by the screening department of NovoBliss Research. Subjects will be called on the telephone by the recruiting department prior to the enrolment visit. They will be asked a series of questions that are provided on the Screener Form (an example template is provided in Appendix III). This form will be saved electronically, and if subjects are eligible for the study as determined by the responses given on the Screener Form, subjects may be asked to participate in the enrolment visit. Subjects will be told during screening (prior to enrolment) not to wear any facial make-up on the study visit day. It is also recommended that the subjects are told to bring a hair tie to pull their hair back if desired during the study.
Assessment of efficacy parameters before application, after product removal at 5 mins, 15mins will be done on day 1 of the study as listed below.
* Skin ColorimeterCL- 400 (Courage Khazaka Instrument): (International Commission on Illumination) CIE L-, a-, b- value, ITA (Individual Topology Angle\] - instant change in skin colour, tone
* Visioscan®VC20plus - SELS (Surface Evaluation of the Living Skin), Pores - Skin Surface Assessment: Roughness, smoothness, texture
* 3D Imaging Pictures
* Sensorial Evaluation-- Subjective evaluation of skin brightness, and skin tanning: on a four-point scale (absent, mild, moderate, or severe)
* Digital Photographs: Before Application and after product removal.
* Local irritation (erythema, scaling, itching, and burning): using a four-point scale (absent, mild, moderate, severe)
* Skin pigmentation scoring
* Subjects Response Index \[Consumer Perception about Product\] Before Application and After product removal
* Product acceptance related to physical properties (consistency, colour, fragrance) on five-point scale
* Product acceptance related to cosmetic properties (spreadability, permeability and fixation) on five-point scale
* Subjects Satisfaction with cosmetic properties
Subjects will be pre-screened by the screening department of NovoBliss Research. Subjects will be called on the telephone by the recruiting department prior to the enrolment visit. They will be asked a series of questions that are provided on the Screener Form (an example template is provided in Appendix III). This form will be saved electronically, and if subjects are eligible for the study as determined by the responses given on the Screener Form, subjects may be asked to participate in the enrolment visit. Subjects will be told during screening (prior to enrolment) not to wear any facial make-up on the study visit day. It is also recommended that the subjects are told to bring a hair tie to pull their hair back if desired during the study.
Assessment of efficacy parameters before application, after product removal at 5 mins, 15mins will be done on day 1 of the study as listed below.
* Skin ColorimeterCL- 400 (Courage Khazaka Instrument): (International Commission on Illumination) CIE L-, a-, b- value, ITA (Individual Topology Angle\] - instant change in skin colour, tone
* Visioscan®VC20plus - SELS (Surface Evaluation of the Living Skin), Pores - Skin Surface Assessment: Roughness, smoothness, texture
* 3D Imaging Pictures
* Sensorial Evaluation-- Subjective evaluation of skin brightness, and skin tanning: on a four-point scale (absent, mild, moderate, or severe)
* Digital Photographs: Before Application and after product removal.
* Local irritation (erythema, scaling, itching, and burning): using a four-point scale (absent, mild, moderate, severe)
* Skin pigmentation scoring
* Subjects Response Index \[Consumer Perception about Product\] Before Application and After product removal
* Product acceptance related to physical properties (consistency, colour, fragrance) on five-point scale
* Product acceptance related to cosmetic properties (spreadability, permeability and fixation) on five-point scale
* Subjects Satisfaction with cosmetic properties
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: