To study the safety, effectiveness of an anti-ageing serum in Healthy Human volunteers.
- Conditions
- Healthy human volunteers with acne scars will be included in the study
- Registration Number
- CTRI/2021/11/038145
- Lead Sponsor
- ITC LIMITED
- Brief Summary
Skin ageing is induced by both intrinsic and extrinsic factors.Intrinsic ageing is an inevitable physiological process which is mainly causedby gradual dermal atrophy, while extrinsic ageing is engendered by externalenvironment factors such as air pollution, smoking, poor nutrition, and sunexposure. Thus resulting in appearance of fine lines and wrinkles,hyperpigmentation spots, and loss of elasticity, firmness. Application of faceserum with effective anti-ageing actives can lead to anti-ageing benefits anddelay signs of ageing, such as reduction in appearance of wrinkles and finelines; hyper pigmentation and uneven skin tone; dryness; increase of firmnessand brightness. This study aimed at the evaluation of anti-ageing andassociated benefits from the test product: Anti-ageing Face Serum.
The study was designed to evaluate the effectiveness of the testproduct in reducing wrinkles and fine lines along with other signs of ageing,and overall improvement in skin condition basis instrumental, Dermatologist andSubject perception.
*The key findings allow for following conclusions:*
· Test product (Product Code AAFS\_1021)conferred significant reduction in fine lines and wrinkle (including deepwrinkles).
· Test product (Product Code AAFS\_1021)conferred significant improvement in pore appearance [i.e., reduced pore visibility,depth, size and density (number of pores per unit area)].
· Test product (Product Code AAFS\_1021) conferredimmediate significant hydration and deep hydration.and deep penetration.
· Test product (Product Code AAFS\_1021)conferred significant reduction in hyperpigmentation (dark spots/age spots/UVspots/Post inflammatory hyperpigmentation) and improvement in luminescence,skin color and firmness.
· Test product (Product Code AAFS\_1021) isNon-sticky & lightweight, does not leave skin feel greasy/oily, or leaveany unwanted residue; gives a soothing feel; instantly moisturized, soft andsupple skin; smoothens skin texture instantly and improves overall appearanceof skin, based on participant self-assessment.
· Test product (Product Code AAFS\_1021) showedefficacy/improvement in fine linesvisibility from the first use and showed improvement day by day; provides evenskin tone and spotless clear skin; reduces dark spots, age spots andhyperpigmentation; reduces pore size, imparts youthful and healthier appearanceto skin and makes skin appear younger looking, more vibrant, repairs skin,gives hydrated, clear and radiant skin and provides excellent anti-ageingbenefits and youth boosting results based on participant self-assessment.
· Test product (Product Code AAFS\_1021) firmsup jawline and neck, fades away deep wrinkles, reduces dark circles and undereye bags based on participant self-assessment.
· Test product (Product Code AAFS\_1021)maintains skin pH / acid mantle of the skin.
· Test product (Product Code AAFS\_1021) doesnot cause any skin irritation and is thus suitable, safe and well tolerated onskin.
*Detailed findings:*
1. Asper instrumental evaluations:
a) There was a significant decrease in theLength of wrinkles on face: at Forehead, Crow’s feet and Nasolabial area, atthe end of 4 weeks, 6 weeks, 8 weeks and 10 weeks as compared with the baseline(all *p*’s *<0.001*).
b) Wrinkles depth showed a significant decreaseat 2 weeks for forehead wrinkles as compared with the baseline (*p<0.05*).
c) For a subset of consumers that showedpresence of deep wrinkles (≥2 mm) in crow ’s feet area, there was a significantdecrease in deep wrinkle length in crow ’s feet area Immediately afterapplication, at the end of 6-weeks, 8 weeks and 10 weeks, as compared with thebaseline (all *p*’s *<0.01*).
d) There was a significant decrease in totalvolume of pores and pore index immediately post application and at 8 weeks ascompared with the baseline (all *p*’s *<0.05*).
e) There was a significant reduction inhyperpigmentation at the end of 4 weeks, 6 weeks, 8 weeks and 10 weeks ascompared with the baseline (all *p*’s *<0.01*).
f) There was a significant increase in skinluminescence at 8 weeks as compared with the baseline (*p<0.05*).
g) There was a significant improvement in skincolor/skin tone at 6 weeks and 8 weeks as compared with the baseline (all *p’*s*<0.05*).
h) There was a significant improvement in SkinFirmness on face (Cheek) from 2 weeks to 10 weeks as compared with the baseline(all *p’*s*<0.05*).
i) pH of skin was maintained in thepH range of 5.4-5.9.
j) Test Product site showed significantlybetter skin hydration than untreated control site until 10th stripping i.e.,Test products penetrates 10 layers deep.
k) Instant improvement in hydration (bothsurface and deep hydration) was found post application as compared with thebaseline (all *p’*s*<0.05*).
l) Significant improvement was observed in deepskin hydration at 10 weeks as compared with the baseline (*p<0.05)*.
2. As per clinical evaluation by the Dermatologist:
a) Mean Score of Wrinkles in Crow’s Feet Areausing Jin Ho Chung Scale showed a significant improvement at 10 weeks ascompared with the baseline (*p<0.05)*.
b) Mean score of Pore severity on entire faceshowed a significant decrease at the end of 4, 6, 8 and 10 weeks as comparedwith the baseline (all *p’*s*<0.05*).
3. Asper self-assessment for efficacy, there was significant improvement at all timepoints (all *p*’s *<0.001*) for
a) Softness
b) Smoothness
c) Firmness
4. Asper self-assessment, post immediate application of the product, 100% ofrespondents agreed that:
· the product is Non-sticky & lightweight
· the product does not leave your skin feelgreasy/oily
· the product gives a soothing feel to yourskin
· the product improves overall appearance ofyour skin
· the product does not leave any unwantedresidue on the skin
· the product makes your skin feel instantlymoisturized
· the product makes your skin feel instantlysoft and supple
· the product smoothens your skin textureinstantly
· the product does not cause any skinirritation and thus is safe for skin.
5. Asper self-assessment, at Week 4, 100% of respondents agreed that:
· the product gives a soothing feel to yourskin
· the product improves overall appearance ofyour skin
· the product started working on fine linesfrom the first use and improved day by day
· the product reduces pore size
· the product provides even skin tone andspotless clear skin
· the product reduces dark spots, age spotsand hyperpigmentation
· the product penetrates deep into the skin togive hydrated, clear and radiant skin
· the product renews, restores & repairsskin
· the product imparts youthful and healthierappearance to your skin
· like the product based on its overallperformance after continuous usage
· the product made their skin appear youngerlooking and more vibrant
· As compared to other anti-ageing productsthey may have used, this product provided excellent anti-ageing benefits andyouth boosting results.
6. Asper self-assessment, at Week 10, 100% of respondents agreed that:
· the product gives a soothing feel to your skin
· the product improves overall appearance ofyour skin
· the product started working on fine linesfrom the first use and improved day by day
· the product reduces pore size
· the product provides even skin tone andspotless clear skin
· the product penetrates deep into the skin togive hydrated, clear and radiant skin
· the product renews, restores & repairsskin
· the product imparts youthful and healthierappearance to your skin
· like the product based on its overallperformance after continuous usage
· the product firms up jawline and neck.
· the product faded away deep wrinkles.
· the product reduces dark circles andundereye bags.
· As compared to other anti-ageing productsthey may have used, this product provided excellent anti-ageing benefits andyouth-boosting results.
7. Thetest product was deemed to be safe as per AE monitoring,Self-assessment-Tolerance (prickling, tingling, itching, burning), and clinicalassessment for safety (erythema, oedema, cutaneous dryness).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 45
- Indian/Asian female subjects 2.
- Healthy subjects between 35 and 60 years of age.
- Skin in healthy state on the studied anatomic site (free of eczema, wounds, cuts, bruises, inflammatory scar).
- Mild to moderate wrinkles in the crow's feet area and/or nasolabial area and/or forehead wrinkle.
- Subjects who have not undergone any facial or anti-ageing procedures (e.g., Botulinum toxin, dermal filler injections, laser resurfacing) in the past 3 months.
- 6.Subject should be willing to abstain from spa treatments/facials during the study period.
- Subjects willing to abide by the study protocol and restriction (refrain from using any product other than provided investigational product (IP)).
- 1.Subjects who are pregnant or nursing (as confirmed by Urine pregnancy test for the determination of Pregnancy) or planning to conceive in coming 4-5 months.
- Subjects with a present condition of allergic response to any cosmetic product.
- Subjects undergoing treatment for any skin care concern.
- Subjects under chronic medication (e.g., aspirin-based products, anti-inflammatories, antihistamines etc.) that might influence the outcome of the study.
- Subjects who has used any systemic medication (antibiotics, oral contraceptive pills, steroids, or any other anti-acne medication) or any topical facial medication with in past 4 weeks.
- Having acne of severe incidence (presence of Nodules, Cysts or numerous pustules) which requires pharmaceutical treatment.
- Subjects with excessive facial hair or scars on test sites (face and volar forearm), which could interfere with evaluation.
- Subjects having cutaneous hypersensitivity.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Instrumental evaluation of Day 0(pre and post prodict application) | Week 1, | Week 2, | Week 4, | Week 6, | Week 8, | Week 10 1.Fine lines, wrinkles , deep wrinkles, pores, smoothness of skin , skin texture, Day 0(pre and post prodict application) | Week 1, | Week 2, | Week 4, | Week 6, | Week 8, | Week 10 hyperpigmentation spots, skin color (L, ITA), by Antera. Day 0(pre and post prodict application) | Week 1, | Week 2, | Week 4, | Week 6, | Week 8, | Week 10 2. Skin firmness on area under the jawline on the neck and elasticity by CutoMeter. Day 0(pre and post prodict application) | Week 1, | Week 2, | Week 4, | Week 6, | Week 8, | Week 10 4. Skin hydration by MMSC. Day 0(pre and post prodict application) | Week 1, | Week 2, | Week 4, | Week 6, | Week 8, | Week 10 3. Skin firmness and elasticity on cheek by CutoMeter Day 0(pre and post prodict application) | Week 1, | Week 2, | Week 4, | Week 6, | Week 8, | Week 10 5. Moisture in the deeper layers of skin by MMD (S15-1.5 mm deep). Day 0(pre and post prodict application) | Week 1, | Week 2, | Week 4, | Week 6, | Week 8, | Week 10 Clinical evaluation of Day 0(pre and post prodict application) | Week 1, | Week 2, | Week 4, | Week 6, | Week 8, | Week 10 6. Skin gloss by Skin Glossmerer Day 0(pre and post prodict application) | Week 1, | Week 2, | Week 4, | Week 6, | Week 8, | Week 10 7. TEWL using VapoMeter. Day 0(pre and post prodict application) | Week 1, | Week 2, | Week 4, | Week 6, | Week 8, | Week 10 1. Jin-Ho-Chung scale for wrinkles in crow’s feet area. Day 0(pre and post prodict application) | Week 1, | Week 2, | Week 4, | Week 6, | Week 8, | Week 10 2. Wrinkles on forehead and in the nasolabial area. Day 0(pre and post prodict application) | Week 1, | Week 2, | Week 4, | Week 6, | Week 8, | Week 10 8. Skin pH by skin- pH- Meter Day 0(pre and post prodict application) | Week 1, | Week 2, | Week 4, | Week 6, | Week 8, | Week 10 3. Pore severity. Day 0(pre and post prodict application) | Week 1, | Week 2, | Week 4, | Week 6, | Week 8, | Week 10
- Secondary Outcome Measures
Name Time Method 1.Clinical evaluation for tolerance 2.Self-assessment questionnaire for efficacy and tolerance.
Trial Locations
- Locations (1)
C.L.A.I.M.S. PVT. LTD.
🇮🇳Mumbai, MAHARASHTRA, India
C.L.A.I.M.S. PVT. LTD.🇮🇳Mumbai, MAHARASHTRA, IndiaDr Rajiv JoshiPrincipal investigator02266758851rsjdrs@gmail.com