Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001735842
Ethics application status
Approved
Date submitted
8/10/2021
Date registered
20/12/2021
Date last updated
28/01/2024
Date data sharing statement initially provided
20/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
No-tox Vs. Retinoid (Tretinoin) Study: Comparison of the wrinkle reduction performance of a cosmeceutical non-toxin based wrinkle-reducing serum against a pharmaceutical prescription-grade retinol
Scientific title
A randomised, controlled comparative study the wrinkle reduction benefits of No-Tox, a plukenetia/niacinamide/plankton-based topical cosmeceutical formulation vs. 0.5 mg (0.05% w/w) tretinoin, a pharmaceutical prescription-strength topical retinoic acid formulation in healthy adults
Secondary ID [1] 305474 0
Nil known
Universal Trial Number (UTN)
U1111-1270-1662
Trial acronym
NOVRET (No-tox Vs. Retinoid Study)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wrinkling due to skin damage caused by exposure to sunlight 323855 0
Condition category
Condition code
Skin 321365 321365 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
No-Tox serum (manufactured under license by Smoothe Inc, DE, USA) will be applied twice daily over wrinkled areas of the face (4-5 drops twice daily as recommended by the manufacturers). The cosmetic formulation contains plukenitia volubis, niacinamide, hyaluronic acid and plankton extracts (detailed ingredient list under documents) Measurements and clinical reviews will be undertaken at 1-month and 3-month periods on healthy adult volunteers. The amount of product provided has been estimated to last 3 months at which the empty containers will be returned.
Intervention code [1] 321877 0
Treatment: Other
Comparator / control treatment
Tretinoin cream (0.5 mg/g) will be applied once daily (pea-sized amount as per manufacturer recommendations) by the comparator group over wrinkled areas of the face. Participants (healthy adult volunteers) will be reviewed at 1 month and 3 month periods and the amount of product provided has been estimated to last 3 months at which the empty containers will be returned.
Control group
Active

Outcomes
Primary outcome [1] 329143 0
Any change in wrinkle count or depth (measured using fluorescence spectroscopic facial scanner)
Timepoint [1] 329143 0
1 month and 3 months after study commencement
Secondary outcome [1] 401624 0
Any skin sensitivity or skin irritation that occurs in either arm of the study will be evaluated using participant questionnaires designed specifically for the study..
Timepoint [1] 401624 0
From Day 1 of treatment until conclusion of the study.

Eligibility
Key inclusion criteria
Healthy volunteers, aged between 25 and 75 without acute or chronic skin diseases will be enrolled.
Minimum age
25 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Anyone with skin diseases, acute or chronic, those unable to provide informed consent, or those with a history of allergies or sensitivities to any of the ingredients in the study products. For females, pregnancy (or planned pregnancy during he study period) will also be an exclusion.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be assigned random numbers using a random number generator program. These random numbers will be sent to the clinic, and the randomisation table will be kept blind by the organisation from the investigators during the research period. Allocation done by department independent of the study centre.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Ultimately, 60 participants will be randomised into two groups of 30 (minimum 20) each.The plan is to aim for 30 subjects allocated to each group, that allows the team to set the statistical power at a minimum of 80% which is a desired minimum benchmark. All statistical evaluation and analyses will be undertaken independently by the Department of Mathematical Sciences of the Auckland University of Technology.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/04/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 24167 0
New Zealand
State/province [1] 24167 0
Auckland

Funding & Sponsors
Funding source category [1] 309830 0
Other Collaborative groups
Name [1] 309830 0
Skin Surgery Clinic
Country [1] 309830 0
New Zealand
Primary sponsor type
Other Collaborative groups
Name
Skin Surgery Clinic
Address
271A Blockhouse Bay Road, Auckland 0600
Country
New Zealand
Secondary sponsor category [1] 310868 0
None
Name [1] 310868 0
None
Address [1] 310868 0
Not applicable
Country [1] 310868 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309572 0
Institutional Ethics Approval
Ethics committee address [1] 309572 0
Ethics committee country [1] 309572 0
New Zealand
Date submitted for ethics approval [1] 309572 0
03/01/2022
Approval date [1] 309572 0
17/02/2022
Ethics approval number [1] 309572 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114630 0
Ms Allanah Knight
Address 114630 0
Skin Surgery Clinic
271A Blockhouse Bay Road
Auckland 0600
Country 114630 0
New Zealand
Phone 114630 0
+6498286438
Fax 114630 0
+6498286432
Email 114630 0
[email protected]
Contact person for public queries
Name 114631 0
Allanah Knight
Address 114631 0
Skin Surgery Clinic
271A Blockhouse Bay Road
Auckland 0600
Country 114631 0
New Zealand
Phone 114631 0
+6498286438
Fax 114631 0
+6498286432
Email 114631 0
[email protected]
Contact person for scientific queries
Name 114632 0
Allanah Knight
Address 114632 0
Skin Surgery Clinic
271A Blockhouse Bay Road
Auckland 0600
Country 114632 0
New Zealand
Phone 114632 0
+6498286438
Fax 114632 0
+6498286432
Email 114632 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data collected during the trial, after de-identification (published results only)
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Other researchers on a case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
To achieve the aims of any approval request received
How or where can data be obtained?
[email protected] (principal investigator)


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.