Skin AgingNCT04276753
A Randomized, Double-blinded, Placebo Controlled, Monocentric Study to Evaluate the Anti-ageing and Skin Brightening Benefit of the Test Product in Healthy Female Subjects
A study testing Terminalia Chebula Fruit Extract in people with Skin Aging, run by Ratan K. Chaudhuri at 1 site in India.
Trial summary
Every day the cells of the outer layer of skin die off, shed, and regenerate. When young, skin cells turn over quickly, but that turnover rate begins to slow with age, beginning as early as twenties. As a result, skin loses its luster and begins to look dull. Read more about this study
- Who is it for?
- Ages 35 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Aging
- What is being tested?
- Terminalia Chebula Fruit Extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteIndia
- Study dates
- 3 Sep 2020to 30 Apr 2021
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female adult subjects in general good health as determined from a recent medical history, general physical examination, dermatological assessment.
- Subjects in the age group of 35-50 years (both ages inclusive).
- Subject with Fitzpatrick skin types III to V (ITA to be recorded at forehead and flexor forearm)
- Subjects with chronic pollution exposure in past 5 years based on pollution questionnaire (Refer annexure 1)
- Subjects with normal to dry skin type (corneometer reading upto 35)
- Subjects with mild to moderate fine lines and wrinkles in periorbital area (Crow's feet-under eye) \& forehead (Refer annexure 3 for photonumerical scale)
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- Subjects with minimum one spot with width ≥3 mm
- Subjects with chronic pollution exposure in past 5 years based on pollution questionnaire (Refer annexure 1)
- Subject free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face.
- Subject who agrees not to use any other product/treatment/home remedy/ except the provided product on their face during the study period other than the test product.
- Subjects who agree not to carry out bleaching or any other procedures including facial etc. on face during the study period.
- Subjects who agree not to expose to excessive sun light. (Sun exposure not more than half an hour daily and during that time use of umbrella to cover face).
- Subjects willing to give a voluntary written informed consent, photography release and agree to come for regular follow-up.
- Subjects willing to abide by and comply with the study protocol.
Who cannot join
- Subject with any other signs of significant local irritation or skin disease.
- Subject currently taking any medication, which the Investigator believes may influence the interpretation of the data.
- Subject having clinically significant systemic or cutaneous disease, chronic illness or had major surgery in the last year.
- Subjects who do not agree to remove all jewellery on/around face (e.g., necklace, earrings, if possible nose ring), during VISIA imaging.
- Subjects having hair style which covers almost the entire forehead
- Subjects undergoing any treatment of any skin condition on their face/forearm.
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- Subjects not willing to discontinue other topical facial products.
- Subject allergic or sensitive to bar cleansing products, cosmetics, creams/lotions, artificial jewellery or anything else.
- Pregnant women (as confirmed by UPT) and lactating women
- Subjects on any medical treatment either systemic/topical in the past 1 month or currently taking medication including food supplements.
- Subjects with skin allergy history or atopic dermatitis or psoriasis
- Subjects who have participated in any other clinical trial in the last 3 months.
- Subjects using oral contraceptive pills or hormonal implants as birth control measures during the study
- Subjects that was treated with Botox/filler /bio stimulatory molecules injection
Trial locations and contacts
1 site in 1 country.
About this study
Every day the cells of the outer layer of skin die off, shed, and regenerate. When young, skin cells turn over quickly, but that turnover rate begins to slow with age, beginning as early as twenties. As a result, skin loses its luster and begins to look dull. Aging caused by the genes is inherited and is called intrinsic (internal) aging. The other type of aging is known as extrinsic (external) aging and is caused by environmental factors, such as exposure to the sun's rays.
Skin ageing is mainly characterized by -
- Decrease in thickness, firmness \& elasticity of skin which results in wrinkles.
- Reduction in antioxidant capacities.
- Formation of spider veins and dark circles under the eyes. This study is proposed to evaluate skin antiaging efficacy along with the brightening attributes on face by visual assessment by Dermatologist, image analysis using VISIA CR, skin elasticity by Cutometer (MPA580) Hydration by Corneometer and skin texture by Antera 3 D and skin lightening/fairness by spectrophotometer, water barrier function by TEWL and to skin pH level by pH meter.
Read the detailed description
Every day the cells of the outer layer of skin die off, shed, and regenerate. When young, skin cells turn over quickly, but that turnover rate begins to slow with age, beginning as early as twenties. As a result, skin loses its luster and begins to look dull. Aging caused by the genes is inherited and is called intrinsic (internal) aging. The other type of aging is known as extrinsic (external) aging and is caused by environmental factors, such as exposure to the sun's rays.
Skin ageing is mainly characterized by -
- Decrease in thickness, firmness \& elasticity of skin which results in wrinkles.
- Reduction in antioxidant capacities.
- Formation of spider veins and dark circles under the eyes.
The epidermis, dermis and subcutaneous tissues are the top, middle and bottom layers of the skin respectively. The top layer shows the wrinkles, age spots, deep lines, and depressions. The skin dermis contains macromolecules, polysaccharides, glycosaminoglycans (GAGs), fibrous protein (collagens, elastin), salts and water which together are known as the extra cellular matrix, responsible for tissue cohesion.
The subcutaneous tissues contain fatty deposits. Another part of the skin is the sebaceous glands that produce sebum which lubricates the skin and keeps it soft and smooth. All three skin layers contribute to the aging process. As a person gets older, less sebum is produced, and this makes the epidermis drier. Dry skin is more prone to wrinkling.
Signs of ageing include facial wrinkles, pigmentation, fine lines, crow's feet and Nasolabial folds. Ageing also impacts texture and elasticity of the skin.
Skin lightening or skin brightening, refer to the application of topical products in an attempt to lighten skin tone and provide an even skin complexion by reduction in melanin. The glow is not dependent on the skin colour of the person, i.e. a darker skin tone person can have very good Skin Glow. However, pigmentation errors like uneven skin tone, blemishes, blotchiness and spots also results in varied reflectance of light from the skin surface and results in dullness of the skin. It is also known that skin hydration, skin texture and pigmentation concerns can impact the skin glow. This study is based on evaluating Skin glow based on the relationship of these attributes.
This study is proposed to evaluate skin antiaging efficacy along with the brightening attributes on face by visual assessment by Dermatologist, image analysis using VISIA CR, skin elasticity by Cutometer (MPA580) Hydration by Corneometer and skin texture by Antera 3 D and skin lightening/fairness by spectrophotometer, water barrier function by TEWL and to skin pH level by pH meter.
- Conditions
- Skin Aging
- Being tested
- Terminalia Chebula Fruit Extract, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terminalia Chebula Fruit ExtractOther
Standardized fruit extract
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Terminalia Chebula fruit extract | Experimental | The test product is an emulsion. It contains Terminalia Chebula fruit extract.
Test product will be applied topically on full face twice a day for 8 weeks. Receives: Other: Terminalia Chebula Fruit Extract |
| Placebo | Placebo comparator | The placebo product is an emulsion with same appearance as the experimental product but without Terminalia Chebula fruit extract.
Placebo emulsion will be applied topically on full face twice a day for 8 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the investigational product for skin aging benefits
Evaluate the antiaging effect of investigational product in 8 weeks w.r.t baseline in comparison to placebo as per below parameters.
- Skin texture ii. Signs of aging iii. Skin elasticity/Firmness iv. Skin wrinkles and expression lines v. Skin dryness
Measured: 8 weeks
Evaluate the investigational product for skin brightening benefits
Evaluate the skin brightening benefit of investigational product in 8 weeks w.r.t. baseline in comparison to placebo as per below parameters.
- Glow and radiance ii. Evenness iii. Clarity iv. Skin colour
Measured: 8 weeks
Secondary outcomes (1)
Evaluate the product safety and tolerance by skin tolerance evaluation by dermatologist.
Evaluate the product safety and tolerance by skin tolerance evaluation by dermatologist.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start3 Sep 2020
- Primary completion20 Jan 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ratan K. Chaudhuri
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Ratan K. Chaudhuri, Sytheon Ltd.
- Investigators
- Dr Mukesh Ramnane, MD, Principal investigator, MSCR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276753
- Sponsor's protocol ID
- SKIN/SYAS/2020-01
- Status last verified
- Jun 2021
- First submitted
- 14 Feb 2020
- Last updated
- 25 Jun 2021
- 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 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Placebo Controlled, Monocentric Study to Evaluate the Anti-ageing and Skin Brightening Benefit of the Test Product in Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT04276753
- Acronym / sponsor ID
- SKIN/SYAS/2020-01
- Conditions
- Skin Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Ratan K. ChaudhuriIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 19 Feb 2020 (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.
Every day the cells of the outer layer of skin die off, shed, and regenerate. When young, skin cells turn over quickly, but that turnover rate begins to slow with age, beginning as early as twenties. As a result, skin loses its luster and begins to look dull. Aging caused by the genes is inherited and is called intrinsic (internal) aging. The other type of aging is known as extrinsic (external) aging and is caused by environmental factors, such as exposure to the sun's rays.
Skin ageing is mainly characterized by -
- Decrease in thickness, firmness \& elasticity of skin which results in wrinkles.
- Reduction in antioxidant capacities.
- Formation of spider veins and dark circles under the eyes. This study is proposed to evaluate skin antiaging efficacy along with the brightening attributes on face by visual assessment by Dermatologist, image analysis using VISIA CR, skin elasticity by Cutometer (MPA580) Hydration by Corneometer and skin texture by Antera 3 D and skin lightening/fairness by spectrophotometer, water barrier function by TEWL and to skin pH level by pH meter.
Detailed description
Every day the cells of the outer layer of skin die off, shed, and regenerate. When young, skin cells turn over quickly, but that turnover rate begins to slow with age, beginning as early as twenties. As a result, skin loses its luster and begins to look dull. Aging caused by the genes is inherited and is called intrinsic (internal) aging. The other type of aging is known as extrinsic (external) aging and is caused by environmental factors, such as exposure to the sun's rays.
Skin ageing is mainly characterized by -
- Decrease in thickness, firmness \& elasticity of skin which results in wrinkles.
- Reduction in antioxidant capacities.
- Formation of spider veins and dark circles under the eyes.
The epidermis, dermis and subcutaneous tissues are the top, middle and bottom layers of the skin respectively. The top layer shows the wrinkles, age spots, deep lines, and depressions. The skin dermis contains macromolecules, polysaccharides, glycosaminoglycans (GAGs), fibrous protein (collagens, elastin), salts and water which together are known as the extra cellular matrix, responsible for tissue cohesion.
The subcutaneous tissues contain fatty deposits. Another part of the skin is the sebaceous glands that produce sebum which lubricates the skin and keeps it soft and smooth. All three skin layers contribute to the aging process. As a person gets older, less sebum is produced, and this makes the epidermis drier. Dry skin is more prone to wrinkling.
Signs of ageing include facial wrinkles, pigmentation, fine lines, crow's feet and Nasolabial folds. Ageing also impacts texture and elasticity of the skin.
Skin lightening or skin brightening, refer to the application of topical products in an attempt to lighten skin tone and provide an even skin complexion by reduction in melanin. The glow is not dependent on the skin colour of the person, i.e. a darker skin tone person can have very good Skin Glow. However, pigmentation errors like uneven skin tone, blemishes, blotchiness and spots also results in varied reflectance of light from the skin surface and results in dullness of the skin. It is also known that skin hydration, skin texture and pigmentation concerns can impact the skin glow. This study is based on evaluating Skin glow based on the relationship of these attributes.
This study is proposed to evaluate skin antiaging efficacy along with the brightening attributes on face by visual assessment by Dermatologist, image analysis using VISIA CR, skin elasticity by Cutometer (MPA580) Hydration by Corneometer and skin texture by Antera 3 D and skin lightening/fairness by spectrophotometer, water barrier function by TEWL and to skin pH level by pH meter.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Terminalia Chebula fruit extract | Experimental | Other: Terminalia Chebula Fruit ExtractThe test product is an emulsion. It contains Terminalia Chebula fruit extract. Test product will be applied topically on full face twice a day for 8 weeks. |
| Placebo | Placebo comparator | Other: PlaceboThe placebo product is an emulsion with same appearance as the experimental product but without Terminalia Chebula fruit extract. Placebo emulsion will be applied topically on full face twice a day for 8 weeks. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Female adult subjects in general good health as determined from a recent medical history, general physical examination, dermatological assessment.
- Subjects in the age group of 35-50 years (both ages inclusive).
- Subject with Fitzpatrick skin types III to V (ITA to be recorded at forehead and flexor forearm)
- Subjects with chronic pollution exposure in past 5 years based on pollution questionnaire (Refer annexure 1)
- Subjects with normal to dry skin type (corneometer reading upto 35)
Key exclusion criteria (14 listed)
- Subject with any other signs of significant local irritation or skin disease.
- Subject currently taking any medication, which the Investigator believes may influence the interpretation of the data.
- Subject having clinically significant systemic or cutaneous disease, chronic illness or had major surgery in the last year.
- Subjects who do not agree to remove all jewellery on/around face (e.g., necklace, earrings, if possible nose ring), during VISIA imaging.
- Subjects having hair style which covers almost the entire forehead
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 |
|---|---|---|
| Terminalia Chebula Fruit ExtractStandardized fruit extract | Other | Terminalia Chebula fruit extract |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Evaluate the investigational product for skin aging benefits
Time frame: 8 weeks
Evaluate the antiaging effect of investigational product in 8 weeks w.r.t baseline in comparison to placebo as per below parameters. i. Skin texture ii. Signs of aging iii. Skin elasticity/Firmness iv. Skin wrinkles and expression lines v. Skin dryness
Evaluate the investigational product for skin brightening benefits
Time frame: 8 weeks
Evaluate the skin brightening benefit of investigational product in 8 weeks w.r.t. baseline in comparison to placebo as per below parameters. i. Glow and radiance ii. Evenness iii. Clarity iv. Skin colour
1 secondary outcome
Evaluate the product safety and tolerance by skin tolerance evaluation by dermatologist.
Time frame: 8 weeks
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 25 Jun 2021.
- 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 Mukesh Ramnane, MD principal investigator
MSCR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Terminalia Chebula Fruit Extract in people with Skin Aging, run by Ratan K. Chaudhuri 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 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 25 Jun 2021. 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?
Evaluate the investigational product for skin aging benefits (time frame: 8 weeks). The study lists 2 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 25 Jun 2021.