WrinkleNCT06123572
A Clinical Study to Assess the Safety and Effectiveness of Anti-Ageing and Skin Brightening Gel
A study testing Anti-Ageing and Skin Brightening Gel in people with Wrinkle and Pigment Skin, run by NovoBliss Research Pvt Ltd at 1 site in India.
Trial summary
This is a Randomized, Interventional, Prospective, Double Blind, Two Arm, Comparative, Parallel, Placebo-Controlled, Safety and Efficacy Study of Anti-Ageing and Skin Brightening Gel. Total of 44 adult female subjects (22 Subjects/Arm) of age 35 - 55 years will be enrolled to get 40 completed subjects (20 Subjects/Arm) Read more about this study
- Who is it for?
- Ages 35 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Wrinkle, Pigment Skin, Aging
- What is being tested?
- Anti-Ageing and Skin Brightening Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteIndia
- Study dates
- 14 Sep 2023to 9 Dec 2023
- 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 35 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 35 to 55 years (both inclusive) at the time of consent.
- Sex: Healthy and non-pregnant/non-lactating females.
- Subjects who are generally in good health as determined by/form recent medical history.
- Female of child bearing capacity must have a self-reported negative pregnancy test.
- Subjects having mild to moderate crows' feet wrinkles.
- Subjects having a score of at least "mild skin aging" based on PGA at screening visit.
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- Subjects having a score of at least "mild skin pigmentation" based on Skin Pigmentation Score at screening visit.
- Subjects having Glogau Skin Age II or III as assessed by the Dermatologist/ Dermatologist Trained Evaluator.
- Subjects who are willing to forgo cosmetic procedures for the duration of the study.
- Subjects who are able to follow their normal skin care routines and to refrain from introducing any new skin care products during the study.
- Subjects who are willing not to introduce any new soaps, cleansers, lotions, creams, or any other face products etc. for the duration of the study.
- Subjects who are willing to give written informed consent and are willing to follow the study procedure.
- Subjects who commit not to use medicated/ prescription anti-ageing and skin brightening products or any other anti-ageing and skin brightening products other than the test products for the entire duration of the study.
- Subjects who are willing to use test products throughout the study period.
Who cannot join
- Subjects having a history of allergy or sensitivity to the test treatments ingredients.
- Subjects who have pre-existing or dormant dermatologic conditions (e.g., psoriasis rashes, eczema, seborrheic dermatitis, acne or any other) that could interfere with the outcome of the study as determined by the Investigator.
- Subjects who have used any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks prior to the start or anticipates having to use at any point during the study.
- Subjects who have applied any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study.
- Subjects not willing to avoid unprotected sun or other UV radiation exposure during the study period.
- Subjects having a history of alcohol or drug addiction.
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- Subjects who have used any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks prior to the start or anticipates having to use at any point during the study.
- Subjects who have applied any topical retinoids or glutathione within 2 weeks of the screening visit or anticipates having to use at any point during the study.
- Subjects not willing to avoid unprotected sun or other UV radiation exposure during the study period.
- Subjects who are currently pregnant/breastfeeding or planning to become pregnant during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Two Arm, Parallel, Placebo-Controlled, Safety and Efficacy Study of Anti-Ageing and Skin Brightening Gel
This is a Randomized, Interventional, Prospective, Double Blind, Two Arm, Comparative, Parallel, Placebo-Controlled, Safety and Efficacy Study of Anti-Ageing and Skin Brightening Gel.
Total of 44 adult female subjects (22 Subjects/Arm) of age 35 - 55 years will be enrolled to get 40 completed subjects (20 Subjects/Arm)
Read the detailed description
There will be a total of 3 visits in the study. The subject will be instructed to visit the facility as per the below visits Visit 01 (Day 01): Screening, Enrolment and Treatment Start Phase (Week 00) Visit 02 (Day 30): Treatment Phase (Week 04) Visit 03 (Day 60): End of Study (Week 08) The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent. Subjects will be asked to not wear any makeup on the face on screening day.
Assessment of efficacy parameters before test products usage will be done on Day 01 after enrolment and after test products usage will be done on Day 30 (± 2 days) and Day 60 (± 2 days) as listed-below.
- PGA scoring using Griffiths scale - skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines, laxity, roughness and sallowness.
- Glogau skin age.
- Skin pigmentation scoring.
- Skin elasticity: Cutometer Dual MPA 580.
- Skin colorimeter CL 400: CIE L*, a* b*, ITA angle, skin brightness, skin pigmentation reduction.
- Skin Glossymeter GL200 - skin glow.
- Visioscan (C+K instrument): crow's feet area wrinkles, fine lines, skin texture - roughness, dryness, wrinkles, smoothness.
- Digital photographs: facial photographs before test products usage on day 1 and post-usage at day 60.
- Image-pro software - image analysis day 01 vs day 60 - wrinkles, fine lines, pores.
- Subjective product perception assessment regarding the test product's effect on skin firmness, appearance, radiance, acne or skin breakouts, glowing skin tone, blemishes and dark skin patches removal etc.
- Conditions
- Wrinkle, Pigment Skin, Aging
- Being tested
- Placebo, Anti-Ageing and Skin Brightening Gel
- Medical subject headings
- Pigmentation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Placebo Comparator
Anti-Ageing and Skin Brightening GelOther
Anti-Ageing and Skin Brightening Gel.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Mode of Usage: Twice a day on clean skin Route of Administration: Topical application. Receives: Other: Placebo |
| Anti-Ageing and Skin Brightening Gel | Experimental | Mode of Usage: Twice a day on clean skin Route of Administration: Topical application. Receives: Other: Anti-Ageing and Skin Brightening Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Skin Elasticity
To assess the effectiveness of the test products in terms of change in Skin Elasticity from "before test product usage" and "after test product usage" using Cutometer Dual MPA 580
Measured: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
Change in CIE L*, a* b*, ITA (Individual Topography Angle), skin brightness, skin pigmentation
To assess the effectiveness of the test products in terms of change in CIE L*, ITA angle, a* and b* from "before test product usage" and "after test product usage" using Skin Colorimeter CL 400.
Measured: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
Change in Skin Glow
To assess the effectiveness of the test products in terms of change in Skin Glow from "before test product usage" and "after test product usage" using Skin Glossymeter GL 200.
Measured: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
Change in crow's feet area wrinkles, fine lines
To assess the effectiveness of the test products in terms of change in crow's feet area wrinkle, fine line from "before test product usage" and "after test product usage" using Visioscan VC 20
Measured: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
Change in Skin texture (wrinkles, fine lines, roughness, dryness, wrinkles, and smoothness) of skin
To assess the effectiveness of the test products in terms of change in Skin texture (wrinkles, fine lines, roughness, dryness, wrinkles, and smoothness) of skin from "before test product usage" and "after test product usage" using Visioscan VC 20
Measured: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
Change in facial photographs
To assess the effectiveness of the test products in terms of change in facial photographs from "before test product usage" and "after test product usage" using digital photographs.
Measured: From baseline (Day 01) before usage of test products to Day 60 (±2 days) post-usage of test products
Change in wrinkles, fine lines and pores
To assess the effectiveness of the test products in terms of change in wrinkles, fine lines and pores from "before test product usage" and "after test product usage" using Image-pro Software.
Measured: From baseline (Day 01) before usage of test products to Day 60 (±2 days) post-usage of test products
Secondary outcomes (4)
Change in Physician Global Assessment (PGA) Score
To assess the effectiveness of test treatment in terms of change in PGA scores i.e. dryness, redness, fine lines, coarse wrinkle, laxity, roughness, and sallowness by using Griffith scale Where 0= No appearance and 9= Severe
Measured: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
Change in Level of skin photodamage
To assess the effectiveness of the test products in terms of change in level of photodamage using Glogau skin age
Measured: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
Change in skin pigmentation
To assess the effectiveness of the test products in terms of change in skin pigmentation using skin pigmentation scoring. Scoring Scale:(0-absent, 1-mild, 2-moderate, 3-severe)
Measured: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
Assessment of Consumer Perception
To assess the consumer perception of the test products regarding the test product's effect on skin firmness, appearance, radiance, acne or skin breakouts, glowing skin tone, blemishes and dark skin patches removal using questionnaire. Scoring Scale: (1- strongly disagree, 2-disagree, 3-neither agree nor disagree, 4-agree, 5-strongly agree).
Measured: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start14 Sep 2023
- Primary completion20 Nov 2023
- Study completion9 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinkleStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a Randomized, Interventional, Prospective, Double Blind, Two Arm, Comparative, Parallel, Placebo-Controlled, Safety and Efficacy Study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Green Mountain Biotech Limited
- Responsible party
- Principal investigator, Dr Nayan Patel, NovoBliss Research Pvt Ltd
- Investigators
- Dr Nayan K Patel, Principal investigator, NovoBliss Research Private Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123572
- Sponsor's protocol ID
- NB230027-GB
- Status last verified
- Dec 2023
- First submitted
- 26 Oct 2023
- Last updated
- 12 Dec 2023
- 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 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Two Arm, Parallel, Placebo-Controlled, Safety and Efficacy Study of Anti-Ageing and Skin Brightening Gel
- ClinicalTrials.gov ID
- NCT06123572
- Acronym / sponsor ID
- NB230027-GB
- Conditions
- Wrinkle, Pigment Skin, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Collaborators
- Green Mountain Biotech Limited
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 9 Dec 2023 (actual)
- First posted
- 9 Nov 2023 (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 a Randomized, Interventional, Prospective, Double Blind, Two Arm, Comparative, Parallel, Placebo-Controlled, Safety and Efficacy Study of Anti-Ageing and Skin Brightening Gel.
Total of 44 adult female subjects (22 Subjects/Arm) of age 35 - 55 years will be enrolled to get 40 completed subjects (20 Subjects/Arm)
Detailed description
There will be a total of 3 visits in the study. The subject will be instructed to visit the facility as per the below visits Visit 01 (Day 01): Screening, Enrolment and Treatment Start Phase (Week 00) Visit 02 (Day 30): Treatment Phase (Week 04) Visit 03 (Day 60): End of Study (Week 08) The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent. Subjects will be asked to not wear any makeup on the face on screening day.
Assessment of efficacy parameters before test products usage will be done on Day 01 after enrolment and after test products usage will be done on Day 30 (± 2 days) and Day 60 (± 2 days) as listed-below.
- PGA scoring using Griffiths scale - skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines, laxity, roughness and sallowness.
- Glogau skin age.
- Skin pigmentation scoring.
- Skin elasticity: Cutometer Dual MPA 580.
- Skin colorimeter CL 400: CIE L*, a* b*, ITA angle, skin brightness, skin pigmentation reduction.
- Skin Glossymeter GL200 - skin glow.
- Visioscan (C+K instrument): crow's feet area wrinkles, fine lines, skin texture - roughness, dryness, wrinkles, smoothness.
- Digital photographs: facial photographs before test products usage on day 1 and post-usage at day 60.
- Image-pro software - image analysis day 01 vs day 60 - wrinkles, fine lines, pores.
- Subjective product perception assessment regarding the test product's effect on skin firmness, appearance, radiance, acne or skin breakouts, glowing skin tone, blemishes and dark skin patches removal etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a Randomized, Interventional, Prospective, Double Blind, Two Arm, Comparative, Parallel, Placebo-Controlled, Safety and Efficacy Study
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboMode of Usage: Twice a day on clean skin Route of Administration: Topical application. |
| Anti-Ageing and Skin Brightening Gel | Experimental | Other: Anti-Ageing and Skin Brightening GelMode of Usage: Twice a day on clean skin Route of Administration: Topical application. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Age: 35 to 55 years (both inclusive) at the time of consent.
- Sex: Healthy and non-pregnant/non-lactating females.
- Subjects who are generally in good health as determined by/form recent medical history.
- Female of child bearing capacity must have a self-reported negative pregnancy test.
- Subjects having mild to moderate crows' feet wrinkles.
Key exclusion criteria (10 listed)
- Subjects having a history of allergy or sensitivity to the test treatments ingredients.
- Subjects who have pre-existing or dormant dermatologic conditions (e.g., psoriasis rashes, eczema, seborrheic dermatitis, acne or any other) that could interfere with the outcome of the study as determined by the Investigator.
- Subjects who have used any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks prior to the start or anticipates having to use at any point during the study.
- Subjects who have applied any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study.
- Subjects not willing to avoid unprotected sun or other UV radiation exposure during the study period.
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 |
|---|---|---|
| PlaceboPlacebo Comparator | Other | Placebo |
| Anti-Ageing and Skin Brightening GelAnti-Ageing and Skin Brightening Gel. | Other | Anti-Ageing and Skin Brightening Gel |
Primary outcome
Change in Skin Elasticity
Time frame: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
To assess the effectiveness of the test products in terms of change in Skin Elasticity from "before test product usage" and "after test product usage" using Cutometer Dual MPA 580
Change in CIE L*, a* b*, ITA (Individual Topography Angle), skin brightness, skin pigmentation
Time frame: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
To assess the effectiveness of the test products in terms of change in CIE L*, ITA angle, a* and b* from "before test product usage" and "after test product usage" using Skin Colorimeter CL 400.
Change in Skin Glow
Time frame: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
To assess the effectiveness of the test products in terms of change in Skin Glow from "before test product usage" and "after test product usage" using Skin Glossymeter GL 200.
Change in crow's feet area wrinkles, fine lines
Time frame: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
To assess the effectiveness of the test products in terms of change in crow's feet area wrinkle, fine line from "before test product usage" and "after test product usage" using Visioscan VC 20
Change in Skin texture (wrinkles, fine lines, roughness, dryness, wrinkles, and smoothness) of skin
Time frame: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
To assess the effectiveness of the test products in terms of change in Skin texture (wrinkles, fine lines, roughness, dryness, wrinkles, and smoothness) of skin from "before test product usage" and "after test product usage" using Visioscan VC 20
Change in facial photographs
Time frame: From baseline (Day 01) before usage of test products to Day 60 (±2 days) post-usage of test products
To assess the effectiveness of the test products in terms of change in facial photographs from "before test product usage" and "after test product usage" using digital photographs.
Change in wrinkles, fine lines and pores
Time frame: From baseline (Day 01) before usage of test products to Day 60 (±2 days) post-usage of test products
To assess the effectiveness of the test products in terms of change in wrinkles, fine lines and pores from "before test product usage" and "after test product usage" using Image-pro Software.
4 secondary outcomes
Change in Physician Global Assessment (PGA) Score
Time frame: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
Change in Level of skin photodamage
Time frame: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
Change in skin pigmentation
Time frame: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
Assessment of Consumer Perception
Time frame: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products
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 12 Dec 2023.
- Individual participant dataSharing planned: No
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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 principal investigator
NovoBliss Research Private Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-Ageing and Skin Brightening Gel in people with Wrinkle and Pigment 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 14 inclusion and 10 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 12 Dec 2023. 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. Some participants in this study may receive a placebo. 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?
Change in Skin Elasticity (time frame: From baseline (Day 01) before usage of test products to Day 30 (±2 days) and Day 60 (±2 days) post-usage of test products). The study lists 7 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 12 Dec 2023.