An interventional study of SkinQ Glow Bright Wonder Mask in Healthy Human Volunteers With Visibly Tanned Skin, sponsored by NovoBliss Research Pvt Ltd. Completed at 1 site in India. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-29.
Sponsored by NovoBliss Research Pvt Ltd · Not applicable, Interventional, and Other
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:
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.
Subjects Response Index [Consumer Perception about Product] Before Application and After product removal
NovoBliss Research Pvt Ltd is the lead sponsor of 45 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
To assess the instant change in skin colour, and tone
To assess the instant change in skin colour, and tone with a single application of the test product using Skin ColorimeterCL-400 by measuring CIE (International Commission on Illumination) L-, a-, b- value, ITA (Individual Topology Angle)
Time frame: On Day 01 before application and after product removal at 5 mins and 15 mins
Surface evaluation of the living skin SELS® (Surface Evaluation of the Living Skin)
To assess the instant change in skin surface i.e. smoothness, roughness, scaliness, wrinkles based on the grey levels of the image in a single application using Visioscan®VC20plus
Time frame: On Day 01 before application and after product removal at 5 mins and 15 mins
To assess the instant change in skin pores
To assess the instant change in skin pores in a single application using Visioscan®VC20plus
Time frame: from the baseline on Day 01 before application and after product removal at 5 mins and 15 mins
Instant change in skin brightness, skin tanning
To assess the effect of the test product in terms of instant change in skin brightness, skin tanning in a single application by dermatologist trained evaluator or dermatologist
Time frame: on Day 01 before application and after product removal at 15 mins
Local Irritation (erythema, scaling, itching, and burning)
To assess the effect of the test product in terms of local irritation (erythema, scaling, itching, and burning) in a single application by dermatologist trained evaluator or dermatologist
Time frame: On Day 01 before application and after product removal at 15 mins
Skin Pigmentation
To assess instant change in skin pigmentation in a single application by dermatologist trained evaluator or dermatologist
Time frame: On Day 01 before application and after product removal at 15 mins
Sensorial Evaluations
Subjective perception questionnaires on the sensorial evaluations of test product will be asked by study staff after the removal of product on physical properties of the product i.e. consistency, colour, fragrance; product cosmetics properties i.e. spreadability, permeability, fixation, and product usage on skin tan reduction, skin brightening, radiance, fading dark spots, glowing skin, smoothness, roughness, scaliness, feel about burning, redness, itching, tingling upon product application
Time frame: Before product application and after 15 mins of post product removal
Treatment Emergent adverse events
Safety will be determined by treatment-emergent adverse events such as unbearable irritation, redness, tingling, dryness of skin, and burning sensation assessed by the Dermatologist or Study Physician
Time frame: On Day 01 after product application and removal
Plan to share: No
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