NCT05499247

A Proof-of-Concept, Safety and Efficacy Study of SkinQ Glow Bright Wonder Mask in Healthy Human Subjects

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: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: NovoBliss Research Pvt Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, single-arm, single-centre, proof-of-concept, safety and efficacy, clinical study of SkinQ Glow Bright Wonder Mask in Healthy Human Subjects and adequate representation of varied skin types \[Normal, Oily, Dry, Combined and Sensitive skin\]. The rationale of the study is to evaluate whether the product SkinQ Glow Bright Wonder Mask is providing an instant skin tanning reduction in 15 mins, smoother, softer and glows skin, and even/brighter complexion in 15 mins, instant improvement in skin brightness and not just a marketing gimmick. It is also to assess the efficacy of the product in its performance for the following parameters: * Tan reduction * Close pores * Makes skin bright and radiant. * Removes tan marks * Fades dark spots of pimple and acne * Gives a glowing look * The texture of the product, experience, acceptability

Detailed description

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

Conditions

• Healthy Human Volunteers With Visibly Tanned Skin

Interventions

Type	Name	Description
OTHER	SkinQ Glow Bright Wonder Mask	Mode of Usage: Cleanse and dry face. Apply 1 tsp or 5g of the product. Apply with clean finger or brush to full face. Leave to dry for 15 minutes. Wipe with wet cotton or rinse with cool water. Route of Administration: Topical

Timeline

• Start date: 2022-08-29
• Primary completion: 2022-09-06
• Completion: 2022-09-14
• First posted: 2022-08-12
• Last updated: 2022-09-29

Locations

1 site across 1 country: India