Slctr

Double-blinded split face left and right randomized, placebo controlled clinical trial to assess the efficacy of an antiwrinkle topical formulation in persons with facial wrinkles attending the Ayurvedic clinic at Battaramulla

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SLCTR Registration Number

SLCTR/2023/014

Date of Registration

23 Jun 2023

The date of last modification

May 31, 2024

Application Summary

Scientific Title of Trial

Double-blinded split face left and right randomized, placebo controlled clinical trial to assess the efficacy of an antiwrinkle topical formulation in persons with facial wrinkles attending the Ayurvedic clinic at Battaramulla

Public Title of Trial

Disease or Health Condition(s) Studied

Facial wrinkles

Scientific Acronym

None

Public Acronym

None

Brief title

Efficacy of an anti-wrinkle topical formulation in persons with facial wrinkles.

Universal Trial Number

U1111-1292-5384

Any other number(s) assigned to the trial and issuing authority

2022/P/076 by ERC, University of Ruhuna

Trial Details

What is the research question being addressed?

Is Link anti-wrinkle cream safe and effective as a topical formulation in reducing wrinkles and improving skin texture and elasticity compared to placebo?

Type of study

Interventional

Study design

Allocation

Randomized controlled trial

Masking

Double blinded : Participants, Investigators, Data analysts, Healthcare providers

Control

Placebo

Assignment

Parallel

Purpose

Treatment

Study Phase

Phase 2

Intervention(s) planned

Study setting: Recruitment of subjects would be from University of Colombo. The measurement of skin parameters will be conducted in a medical clinic in Battaramulla under the supervision of a specialist Dermatologist.

Study design: Link Antiwrinkle cream will be applied as per protocol using 30 participants enrolled based on inclusion/ exclusion criteria with informed written consent and conducted as a double blinded, split face left and right randomized, placebo controlled clinical study. Participants for the study will be recruited through an open advertisement.

Intervention: The test product comprises multiple anti-aging vitamins, bio peptides and a blend of time- tested herbal ingredients used in ancient Ayurveda and traditional systems of medicines for retaining youthful appearance. The test product contains the following: Gotukola (Centella asiatica), Monarakudumbiya (Vernonia cinerea), Nelli (Phyllanthus emblica), Sandalwood (Santalum album), Stamens of Lotus flowers (Nelumbo nucifera), Stamens of Na flowers (Mesua ferrea) and Shea butter (Butyrospermum parkii) as herbal actives and non herbal actives are natural vitamin E (tocopheryl acetate), palmitoyl tripeptide-1, palmitoyl tetrapeptide-7, sodium ascorbyl phosphate and vitamin A palmitate (retinyl palmitate). The test product and the placebo product is applied on the same person, as per the randomization of left and right sides of the face at night daily after cleaning the face with the given mild cleanser, for 12 weeks.

Placebo: Placebo does not contain herbal actives, vitamins and biopeptides present in test product and it consists only the base ingredients that are approved for use by local and international cosmetic regulatory requirements.

Inclusion criteria

Male and female subjects who are in the age group 35 (minimum age) – 65 (maximum age) years with modified Fitzpatrick wrinkle scale class 1 to 3. Same wrinkles grading should be present in both left and right sides of face (corners of the eyes, forehead, nasolabial fold and around mouth /marionette lines).

Exclusion criteria

Subjects who had surgery on the measured area of the face.
Subjects already on medication for skin improvement (supplements/oral marine collagen).
Subjects with any systemic disorder with skin manifestations or facial dermatoses or acne that would confound interpretation of the study results (e.g., atopic dermatitis, eczema, psoriasis or cancer etc.).
Female subjects who are pregnant (positive urine pregnancy test) or lactating or who are planning to become pregnant or get married during the study period.
Subjects who have started, stopped or changed hormonal treatment (e.g., contraception, thyroid etc.) in the 3 months prior the study commencement.
Subjects with hypersensitivity to any cosmetic products used previously.
Subjects who have received rejuvenating treatment in the past 3 months.
Subjects who are having scleroderma and connective tissue diseases .
Subjects who are on recent physician directed facial rejuvenation treatments botox/peeling/laser/dermal fillers /microneedling etc…)

Primary outcome(s)

1. Determination of change in wrinkles overall size, average depth, average width, maximum depth and indentation index assessed by using the Antera 3 D camera.	[ Baseline (prior to the commencement of intervention), 4 th week, 8 th week and 12 th week after the baseline ]
2. Determination of change in skin texture as a roughness value assessed using the Antera 3 D camera.	[ Baseline (prior to the commencement of intervention), 4 th week, 8 th week and 12 th week after the baseline ]
3. Determination of change in skin elasticity assessed using the cutometer dual MPA 580.	[ Baseline (prior to the commencement of intervention), 4 th weeks, 8 th weeks and 12 th weeks after the baseline ]

Secondary outcome(s)

Determination of safety of Link Anti wrinkle cream by determining the percentage of persons who experienced adverse events/ adverse reactions.

[
The outcome will be monitored through out the project
]

Sensory evaluation of the product as assessed by a questionnaire developed using American Society for Testing and Materials (E1490-19) - Standard Guide for Two Sensory Descriptive Approaches for Skin Creams and lotions, 2020: Consumer Behavior Descriptive Analysis. The organoleptic properties such as smell/aroma, appearance and texture (feeling of the cream applying on the skin for the stickiness, easy to apply) of the product are ranked for the given scale. Also the after effect of applying the cream and overall acceptability of the product are ranked in the given scale

[
The outcome will be monitored in 4 th week, 8 th week and 12 th week
]

Target number/sample size

30 (half face in each arm)

Countries of recruitment

Sri Lanka

Anticipated start date

2023-08-01

Anticipated end date

2023-12-01

Date of first enrollment

Date of study completion

Recruitment status

Pending

Funding source

Link Natural Products (Pvt) Ltd

Regulatory approvals

Not applicable

State of Ethics Review Approval

Status

Approved

Date of Approval

2023-02-16

Approval number

2022/P/076

Details of Ethics Review Committee

Name:	Ethics Review Committee of the Faculty of Medicine, University of Ruhuna
Institutional Address:	Faculty of Medicine, University of Ruhuna, P.O. Box 70, Galle, Sri Lanka
Telephone:	+094 091 2232288 Ext:161
Email:	ethics@med.ruh.ac.lk

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Prof. Jennifer Perera
Principal Investigator
Faculty of Medicine, University of Colombo, 25, Kynsey Road, Colombo 08, Sri Lanka.

0776096002

jennifer_perera55@yahoo.com

Contact Person for Public Queries

Prof. Jennifer Perera
Principal Investigator
Faculty of Medicine, University of Colombo, 25, Kynsey Road, Colombo 08, Sri Lanka.

0776096002

jennifer_perera55@yahoo.com

Primary study sponsor/organization

Link Natural Products (Pvt) Ltd
NIL
Delgoda - Giridara Road, Malinda, Kapugoda
+9411 5606060
+94112409293
info@linknaturalproducts.com
www.linknaturalproducts.com

Secondary study sponsor (If any)

Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

Yes

IPD sharing plan description

Data will be shared: of Individual participant data that underlie the results being reported, after de-identification (text, tables, figures and appendices). The study protocol data will be available beginning 3 months and ending 5 years following article publication. Data will be shared initially with investigator team and DSMB approved by ERC and later anyone who wishes to access the data in order to achieve the aims of an approved proposal. Proposals should be directed to info@linknaturalproducts.com . To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years from the time of publication. Data link will be created when data is generated after completion of the project.

Study protocol available

Yes

Protocol version and date

Version number: 2.0; 17th January 2023 (ERC approved study protocol)

Protocol URL

Results summary available

Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results