Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000090718
Ethics application status
Approved
Date submitted
30/11/2021
Date registered
24/01/2022
Date last updated
20/01/2023
Date data sharing statement initially provided
24/01/2022
Date results information initially provided
20/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A Double Blind, Placebo Controlled, Randomised Skin Appearance Study on a Pro-Biotic Supplement
Scientific title
A Double Blind, Placebo Controlled, Randomised Skin Appearance Study on a Pro-Biotic Supplement in Adults with Dry, Sensitive Skin
Secondary ID [1] 306065 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
skin appearance 323902 0
Dry and sensitive skin
 323903 0
Condition category
Condition code
Skin 321415 321415 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An oral NZMP™ probiotic supplementation for improvement of skin appearance. Two doses will be used for the probiotics (a high dose of 6 X10^9 CFU and a low dose of 5X10^8 CFU). This will be compared to a placebo. The duration of the study will be 12 weeks. Participants will consume one capsule per day at home. Capsule will be provided at each visit. Participants will be randomly allocated to the High dose group, Low dose group and to the placebo group. At each visit, participants will return the capsule bottles and compliance will be checked.
Intervention code [1] 321913 0
Treatment: Other
Comparator / control treatment
The placebo group will receive capsules containing maltodextrin powder. They will take one capsule per day at home. Capsule will be provided each visit.
Control group
Placebo

Outcomes
Primary outcome [1] 329192 0
to evaluate the efficacy of a probiotic to improve skin moisture assessed by measuring the electrical properties of the stratum corneum. Skin capacitance will be measured using a Corneometer (www.courage-khazaka.de). Three individual measurements will be taken at different positions within the test site according to the randomisation.
Timepoint [1] 329192 0
12 weeks after starting treatment
Secondary outcome [1] 401742 0
Erythema will be measured using a Chromameter CR400 (www.konicaminolta.com).
Timepoint [1] 401742 0
12 weeks after starting treatment

Eligibility
Key inclusion criteria
1. Aged 30 - 65 years.
2. Volunteers who have visible signs of skin dryness and sensitivity, including dry patches, tight rough skin, redness.
3. Volunteers who have completed a sensitive skin questionnaire and achieved the minimum score.
4. Volunteers who are generally healthy with no significant concurrent illnesses or skin disease.
5. Volunteers who have signed the consent form after the nature of the study has been fully explained.
6. Volunteers who are willing to cooperate and participate by following Study requirements.
7. Volunteers who have received a COVID-19 Vaccine and are able to show their vaccine card at consent.
8. Volunteers who have not travelled outside the UK in the last two weeks before starting treatment.
Minimum age
30 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Pregnant or breastfeeding or lactating females at the start of the study or have given birth within the previous 6 weeks or are planning to become pregnant during the study.
2. Volunteers who have taken part in a Health Research Authority or MHRA regulated clinical trial (e.g. at a hospital or phase I unit) within the previous eight weeks. Volunteers who have taken part in a study involving the face within the previous four weeks.
3. Volunteers with a recent history (previous 12 months) of significant skin disease requiring medical intervention, e.g. Dermatology outpatient appointment.
4. Volunteers that have a history of skin cancer on the test areas.
5. Volunteers with a recent exposure (previous four weeks) to the sun or sun beds, moderate to pronounced suntan, tattoos, scars or other disfiguration, significant dilated vessels, or other conditions on the test area that, in the opinion of the investigators, might influence the test results.
6. Volunteers with inflammatory acne lesions (i.e., papules, pustules, cysts, nodules) at the test site.
7. Volunteers currently using topically applied prescription medications on/near the test site.
8. Volunteers who have had chemical peels, dermabrasion or facial cosmetic surgery within the last six months.
9. Volunteers currently taking, or have taken within the last 3 months, an oral pro-biotic product.
10. Volunteers currently using topical products, prescription or cosmetic, containing retinoids and derivatives or alpha and beta hydroxy acids
11. Individuals with known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs.
12. Volunteers who have recently made significant dietary changes, including removal of gluten, wheat, dairy or eggs from the diet within the 3 month period prior to study enrolment.
13. Volunteers who currently have symptoms associated with CoVid19 (high temperature, a new continuous cough, loss or change in sense of taste and smell), those who have been advised to self-isolate.

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)
Numbered containers provided by the sponsor and blinded to the CRO
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2022
Actual
9/05/2022
Date of last participant enrolment
Anticipated
Actual
28/08/2022
Date of last data collection
Anticipated
Actual
16/11/2022
Sample size
Target
120
Accrual to date
Final
124
Recruitment outside Australia
Country [1] 24183 0
United Kingdom
State/province [1] 24183 0

Funding & Sponsors
Funding source category [1] 309877 0
Commercial sector/Industry
Name [1] 309877 0
Fonterra Cooperative Group Limited
Country [1] 309877 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fonterra Cooperative Group Limited
Address
Private bag 11029
Fitzherbert
Palmerston North 4472
Dairy farm Road
Country
New Zealand
Secondary sponsor category [1] 310908 0
None
Name [1] 310908 0
Address [1] 310908 0
Country [1] 310908 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309606 0
Reading Independent Ethics Committee
Ethics committee address [1] 309606 0
93 Reading Road
Woodley
RG5 3AE
Ethics committee country [1] 309606 0
United Kingdom
Date submitted for ethics approval [1] 309606 0
02/09/2021
Approval date [1] 309606 0
17/09/2021
Ethics approval number [1] 309606 0

Summary
Brief summary
The primary objective of the study is to evaluate the efficacy of a probiotic to provide benefits to dry and sensitive skin when taken as an oral supplement over 12 weeks. A secondary objective is to determine whether there is a dose dependent effect by comparing 2 doses against a placebo formulation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114746 0
Mr Stewart Long
Address 114746 0
Cutest Systems Ltd
Pendragon House
Caxton Place
Pentywn
Cardiff
CF23 8XE
Country 114746 0
United Kingdom
Phone 114746 0
+442920625686
Fax 114746 0
Email 114746 0
Stewart@cutest.co.uk
Contact person for public queries
Name 114747 0
Mr Stewart Long
Address 114747 0
Cutest Systems Ltd
Pendragon House
Caxton Place
Pentywn
Cardiff
CF23 8XE
Country 114747 0
United Kingdom
Phone 114747 0
+44 29 2062 5686
Fax 114747 0
Email 114747 0
Stewart@cutest.co.uk
Contact person for scientific queries
Name 114748 0
Dr Maher Fuad
Address 114748 0
Fonterra Cooperative Group Limited
Private Bag 11029
Fitzherbert
Palmerston North 4472
Dairy Farm Road
Country 114748 0
New Zealand
Phone 114748 0
+64 212153106
Fax 114748 0
Email 114748 0
maher.fuad@fonterra.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to possible intellectual property development


What supporting documents are/will be available?

No Supporting Document Provided



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.