Healthy Human Volunteers With Visibly Tanned SkinNCT05499247
A Proof-of-Concept, Safety and Efficacy Study of SkinQ Glow Bright Wonder Mask in Healthy Human Subjects
A study testing SkinQ Glow Bright Wonder Mask in people with Healthy Human Volunteers With Visibly Tanned Skin, run by NovoBliss Research Pvt Ltd at 1 site in India.
Trial 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]. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Human Volunteers With Visibly Tanned Skin
- What is being tested?
- SkinQ Glow Bright Wonder Mask
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteIndia
- Study dates
- 29 Aug 2022to 14 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18 to 55 years (both inclusive) old at the time of consent.
- Sex: Healthy adult males and non-pregnant/non-lactating females.
- Subject with normal Fitzpatrick skin type III to VI (Human skin colour determination scale).
- Females of childbearing potential must have a self-reported negative urine pregnancy test.
- Subjects are generally in good general health as determined from recent medical history.
- Subjects with visibly tanned skin determine by a dermatologist or dermatologist trained evaluator.
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- The subject does not have any previous history of adverse skin conditions and is not under any medication likely to interfere with the results.
- 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.
- The subject is willing and able to follow the study directions, and participate in the study.
- The subject must be able to understand and provide written informed consent to participate in the study.
Who cannot join
- 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.
- The subject had a facial or chemical peeling or derma abrasion | roller etc. in the last 4 weeks.
- The subject has skin irritation, open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the face that can interfere with the reading.
- Be wearing any facial makeup, including false eyelashes, on the day of the study visit.
- Be using any skin lightening | brightening or tanning removal product within 15 days and on the day of the study visit.
- Medication which may affect skin response and/or past medical history.
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- The subject has a history of diabetes
- 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.
- The subject suffering from any active clinically significant skin diseases which may contraindicate.
- The subject has a history of any skin diseases including eczema, atopic dermatitis etc.
- Subject with self-reported immunological disorders such as HIV positive, AIDS and/or systemic lupus erythematosus.
- 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.
- 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.
- Participation in other clinical studies simultaneously.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
Read the 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
- Being tested
- SkinQ Glow Bright Wonder Mask
- Keywords
- Healthy, Tanned Skin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SkinQ Glow Bright Wonder MaskOther
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
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Other: SkinQ Glow Bright Wonder Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: from the baseline on Day 01 before application and after product removal at 5 mins and 15 mins
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: Before product application and after 15 mins of post product removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start29 Aug 2022
- Primary completion6 Sep 2022
- Study completion14 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Human Volunteers With Visibly Tanned SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Proof-of-Science, Safety and Efficacy
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Nayan Patel, NovoBliss Research Pvt Ltd
- Investigators
- Dr Nayan K Patel, MBBS, Principal investigator, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499247
- Sponsor's protocol ID
- NB220018-SQ
- Status last verified
- Sep 2022
- First submitted
- 3 Aug 2022
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05499247
- Acronym / sponsor ID
- NB220018-SQ
- Keywords
- Healthy, Tanned Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Study start
- 29 Aug 2022 (actual)
- Primary completion
- 6 Sep 2022 (actual)
- Study completion
- 14 Sep 2022 (actual)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Proof-of-Science, Safety and Efficacy
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Other: SkinQ Glow Bright Wonder Mask |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age: 18 to 55 years (both inclusive) old at the time of consent.
- Sex: Healthy adult males and non-pregnant/non-lactating females.
- Subject with normal Fitzpatrick skin type III to VI (Human skin colour determination scale).
- Females of childbearing potential must have a self-reported negative urine pregnancy test.
- Subjects are generally in good general health as determined from recent medical history.
Key exclusion criteria (14 listed)
- 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.
- The subject had a facial or chemical peeling or derma abrasion | roller etc. in the last 4 weeks.
- The subject has skin irritation, open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the face that can interfere with the reading.
- Be wearing any facial makeup, including false eyelashes, on the day of the study visit.
- Be using any skin lightening | brightening or tanning removal product within 15 days and on the day of the study visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SkinQ Glow Bright Wonder MaskMode 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 | Other | Single Arm |
Primary outcome
To assess the instant change in skin colour, and tone
Time frame: On Day 01 before application and after product removal at 5 mins and 15 mins
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)
Surface evaluation of the living skin SELS® (Surface Evaluation of the Living Skin)
Time frame: On Day 01 before application and after product removal at 5 mins and 15 mins
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
To assess the instant change in skin pores
Time frame: from the baseline on Day 01 before application and after product removal at 5 mins and 15 mins
To assess the instant change in skin pores in a single application using Visioscan®VC20plus
4 secondary outcomes
Instant change in skin brightness, skin tanning
Time frame: on Day 01 before application and after product removal at 15 mins
Local Irritation (erythema, scaling, itching, and burning)
Time frame: On Day 01 before application and after product removal at 15 mins
Skin Pigmentation
Time frame: On Day 01 before application and after product removal at 15 mins
Sensorial Evaluations
Time frame: Before product application and after 15 mins of post product removal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Nayan K Patel, MBBS principal investigator
Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SkinQ Glow Bright Wonder Mask in people with Healthy Human Volunteers With Visibly Tanned Skin, run by NovoBliss Research Pvt Ltd at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the instant change in skin colour, and tone (time frame: On Day 01 before application and after product removal at 5 mins and 15 mins). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.