Clinical trial NCT05499247: A Proof-of-Concept, Safety and Efficacy Study of SkinQ Glow Bright Wonder Mask in Healthy Human Subjects
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Human Volunteers With Visibly Tanned Skin
Keywords: Healthy
Tanned Skin
Lead sponsor: NovoBliss Research Pvt Ltd
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Proof-of-Science, Safety and Efficacy
Primary purpose: OTHER

Brief 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

Eligibility criteria: Inclusion Criteria:

1. Age: 18 to 55 years (both inclusive) old at the time of consent.
2. Sex: Healthy adult males and non-pregnant/non-lactating females.
3. Subject with normal Fitzpatrick skin type III to VI (Human skin colour determination scale).
4. Females of childbearing potential must have a self-reported negative urine pregnancy test.
5. Subjects are generally in good general health as determined from recent medical history.
6. Subjects with visibly tanned skin determine by a dermatologist or dermatologist trained evaluator.
7. The subject does not have any previous history of adverse skin conditions and is not under any medication likely to interfere with the results.
8. The subjects who have not done any facial treatment, or any herbal facial, tanning removal for more than 30 days and who regularly use tanning removal products.
9. The subject is willing and able to follow the study directions, and participate in the study.
10. The subject must be able to understand and provide written informed consent to participate in the study.

Exclusion Criteria:

1. Subject with known allergy or sensitization to product ingredients such as niacinamide, glycolic acid, Liquorice, vitamin c, mulberries, purple brazilian clay or any other ingredients.
2. The subject had a facial or chemical peeling or derma abrasion \| roller etc. in the last 4 weeks.
3. The subject has skin irritation, open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the face that can interfere with the reading.
4. Be wearing any facial makeup, including false eyelashes, on the day of the study visit.
5. Be using any skin lightening \| brightening or tanning removal product within 15 days and on the day of the study visit.
6. Medication which may affect skin response and/or past medical history.
7. The subject has a history of diabetes
8. The subject has a history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
9. The subject suffering from any active clinically significant skin diseases which may contraindicate.
10. The subject has a history of any skin diseases including eczema, atopic dermatitis etc.
11. Subject with self-reported immunological disorders such as HIV positive, AIDS and/or systemic lupus erythematosus.
12. Have taken antihistamines (including those in cold tablets, OTC (over-the-counter) allergy medications, decongestants and inhalants) or analgesics (including aspirin or other over-the-counter analgesics) on the days of the study.
13. An individual who has a medical condition or is taking or has taken a medication which, in the Investigator's judgment, makes the subject ineligible or places the subject at undue risk.
14. Participation in other clinical studies simultaneously.

Primary outcomes:
measure: To assess the instant change in skin colour, and tone
timeFrame: On Day 01 before application and after product removal at 5 mins and 15 mins
measure: Surface evaluation of the living skin SELS® (Surface Evaluation of the Living Skin)
timeFrame: On Day 01 before application and after product removal at 5 mins and 15 mins
measure: To assess the instant change in skin pores
timeFrame: from the baseline on Day 01 before application and after product removal at 5 mins and 15 mins
Secondary outcomes:
measure: Instant change in skin brightness, skin tanning
timeFrame: on Day 01 before application and after product removal at 15 mins
measure: Local Irritation (erythema, scaling, itching, and burning)
timeFrame: On Day 01 before application and after product removal at 15 mins
measure: Skin Pigmentation
timeFrame: On Day 01 before application and after product removal at 15 mins
measure: Sensorial Evaluations
timeFrame: Before product application and after 15 mins of post product removal
Other outcomes:
measure: Treatment Emergent adverse events
timeFrame: On Day 01 after product application and removal
Locations:
city: Gandhi Nagar
country: India
facility: NovoBliss Research Pvt Ltd
state: Gujarat
Study officials:
affiliation: Medical Director
name: Dr Nayan K Patel, MBBS
role: PRINCIPAL_INVESTIGATOR
References: