Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001202752
Ethics application status
Approved
Date submitted
1/09/2022
Date registered
8/09/2022
Date last updated
21/09/2023
Date data sharing statement initially provided
8/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A usAbility and experieNce human Study on SWisse's AcnE
suppoRt product (ANSWER)
Scientific title
Investigating the effect of Swisse's acne support product on the incidence of inflammatory skin lesions in young adults
Secondary ID [1] 307889 0
ACN001
Universal Trial Number (UTN)
Trial acronym
ANSWER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acne 327519 0
Condition category
Condition code
Skin 324626 324626 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study involves the testing for eight weeks of a regulatory approved acne support supplement, that has been purposefully designed with ingredients that have scientific evidence supporting their role in acne vulgaris, across all age groups and genders. The product has been manufactured to the highest of standards, has undergone quality assessments and is approved by the Therapeutics Goods Administration (TGA) for safety, quality, and efficacy.
The product Swisse Beauty Acne Support is TGA-listed (ARTG Entry: 384151). The use post-marketing of the product is as per label.

The product tablets are administered orally once a day, preferably with food.

Active Ingredients:
ascorbic acid 100 mg
Camellia sinensis leaf Extract dry concentrate standardised 50 mg
Equivalent: Camellia sinensis (Dry) 1.625 g
d-alpha-tocopheryl acid succinate 24.69 mg
nicotinamide 50 mg
selenomethionine .186 mg
Equivalent: selenium .075 mg
Silybum marianum fruit Extract dry concentrate standardised 518.5 mg
Equivalent: Silybum marianum (Dry) 36.295 g
zinc amino acid chelate 75 mg
Equivalent: zinc 15 mg

Number of tablets left at the end of he study to be collected - just enough product for 8-week test to be supplied.

The product will weigh approximately 65g. The plastic vial is 150mL x 53mm in volume
(roughly 9cm tall, 5cm wide).
Each product vial includes 60 tablets. One room temperature shipment is planned per eligible
participant (n=140). The product presentation is a film coated tablet, route of administration is
oral, and frequency of intake is once a day. Product is advised to be stored below 25°C in a
cool, dry place. The product should not be used if cap seal is broken
Intervention code [1] 324347 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332444 0
Number of participants effectiveness, measured by change in inflammatory and non-inflammatory self-reported lesion count (as composite)
Timepoint [1] 332444 0
Baseline and 8 weeks post-intervention commencement.
Primary outcome [2] 332482 0
Number of participants effectiveness, measured by change in self-reported inflammatory lesion count
Timepoint [2] 332482 0
Baseline and 8 weeks post-intervention commencement.
Primary outcome [3] 332483 0
Number of participants effectiveness, measured by change in self-reported non-inflammatory lesion count
Timepoint [3] 332483 0
Baseline and 8 weeks post-intervention commencement.
Secondary outcome [1] 413525 0
To evaluate the effectiveness of the Swisse Acne Support product, as measured by change of self-reported subjective assessments of acne symptoms by participants.
Timepoint [1] 413525 0
Baseline and 8 weeks post-intervention commencement
Secondary outcome [2] 413526 0
To evaluate the effectiveness of the Swisse Acne Support product, as measured by change of self-reported subjective assessments of skin health by participants
Timepoint [2] 413526 0
Baseline and 8 weeks post-intervention commencement.
Secondary outcome [3] 413527 0
To evaluate the effectiveness of the Swisse Acne Support in improving quality of life through assessment of acne specific QoL questionnaires (i.e, Acne impact in adult daily life (AI-ADL)) and bespoke questions specifically design for this study
Timepoint [3] 413527 0
Baseline and 8 weeks post-intervention commencement.
Secondary outcome [4] 413528 0
To assess overall satisfaction with the Swisse Acne Support product via study-specific question
Timepoint [4] 413528 0
8 weeks post-intervention commencement.
Secondary outcome [5] 413529 0
To assess willingness to buy the Swisse Acne Support product via study-specific question
Timepoint [5] 413529 0
8 weeks post-intervention commencement.
Secondary outcome [6] 413530 0
To assess willingness to recommend the Swisse Acne Support product via study-specific question
Timepoint [6] 413530 0
8 weeks post-intervention commencement.

Eligibility
Key inclusion criteria
Participants must meet all inclusion criteria in order to be eligible to participate in the study:
1. Evidence of an electronically signed and dated informed consent form indicating that the participant has been informed of all pertinent aspects of the study.

2. Aged between 18 and 30 years, both inclusive.

3. Self-reported mild to moderate active acne vulgaris lesions as per DermNet classification criteria.

4. Self-reported absence of any chronic health conditions or co-morbidities, and absence of any medication relating to such conditions. Only allowed medication are: anti-depressants, anti-anxiolytic, anti-histamine, and contraceptives.

5. Body mass index (BMI) lower than 30

6. Female subjects of child-bearing potential are eligible if:
• currently using the same reliable hormonal contraceptive method (oral contraceptive, implant, intra-uterine device, patch, vaginal ring, or injection) for at least 3 months prior to study inclusion and throughout the study or
• currently using a reliable non-hormonal contraceptive method (copper intra-uterine device, condoms, diaphragm, cervical cap or spermicide) for at least 1 month prior to study inclusion and throughout the study or
• have no sexual intercourse and agreeing not to have any throughout the study or
• are surgically sterile (oophorectomy, hysterectomy or tubal ligation).

7. Individuals who agree to continue their “usual” skin care routine.

Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants meeting any of the following criteria will not be eligible to participate in the study:

1. Individuals with severe acne/acne vulgaris (e.g., nodulocystic or cystic acne)

2. Individuals who are currently on systemic therapies and/or prescribed medical topical therapy for the treatment of acne, such as oral retinoids, androgen receptor blockers (e.g., spironolactone), hormonal therapy (not inclusive of the oral contraceptive pill – this is permitted), systemic anti-inflammatory drugs, systemic antibiotics for acne treatment (e.g., doxycycline), topical retinoid and topical prescription antibiotics.
3. Individuals who have been diagnosed with polycystic ovarian syndrome (PCOS). The mechanism of acne in this population group varies to that of a general population.

4. Individuals who are pregnant and/or lactating, or who are planning to become pregnant during the study or 6 weeks after the study

5. Individuals who are currently taking any other supplement (e.g., (multi)vitamins, minerals, omega-3 fatty acids (EPA, DHA, ALA), fibre, herbal, sports nutrition (creatine, branched-chain amino acids), weight management, prebiotics, probiotics)

6. Individuals with known or suspected intolerance or hypersensitivity to the product ingredients (or closely related compounds) or any of their stated ingredients i.e., ascorbic acid (Vitamin C), Camellia sinensis, d-alpha-tocopheryl acid succinatenicotinamide (Vitamin E), selenium, Silybum marianum, and zinc; and excipients i.e., calcium carbonate, calcium hydrogen phosphate dihydrate, Carnauba Wax, colloidal anhydrous silica, croscarmellose sodium, crospovidone, Hypromellose, isomalt, macrogol, magnesium stearate, medium chain triglycerides, microcrystalline cellulose and povidone.

7. Individuals who have participated in any other study (including cosmetic studies) or have received any investigational drug within 30 days of the screening.

8. Personnel:
i. An employee of the sponsor or the study site or members of their immediate family
ii. A person who is engaged in the production, marketing or supply of the goods (a relevant person);
iii. A person who is engaged in the marketing or supply of therapeutic goods includes influencers, direct sellers and other persons who have, or will receive, valuable consideration for making the testimonial.
iv. A member of a relevant person’s immediate family, unless the advertisement discloses that the person who made the testimonial is an immediate family member of the relevant person;
v. Employees or contractors of a government or government authority, a hospital, or healthcare facility, other than a community pharmacy;
vi. A current or former health practitioner, health professional or medical researcher;
vii. A person who represents themselves as being qualified or trained to diagnose, treat or prevent disease, ailment, defect or injury in persons;

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/01/2023
Actual
19/01/2023
Date of last participant enrolment
Anticipated
6/04/2023
Actual
30/05/2023
Date of last data collection
Anticipated
11/08/2023
Actual
13/09/2023
Sample size
Target
140
Accrual to date
Final
211
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 312164 0
Commercial sector/Industry
Name [1] 312164 0
Swisse Wellness Pty Ltd
Country [1] 312164 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Swisse Wellness Pty Ltd
Address
111 Cambridge Street, Collingwood, Victoria 3066, Australia
Country
Australia
Secondary sponsor category [1] 313693 0
None
Name [1] 313693 0
Address [1] 313693 0
Country [1] 313693 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311553 0
Bellberry Limited
Ethics committee address [1] 311553 0
Ethics committee country [1] 311553 0
Australia
Date submitted for ethics approval [1] 311553 0
30/08/2022
Approval date [1] 311553 0
06/01/2023
Ethics approval number [1] 311553 0
2022-08-932

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

Contacts
Principal investigator
Name 121514 0
Mrs Maureen Hitschfeld
Address 121514 0
IQVIA Solutions Pty Ltd, Level 8, 201 Pacific Highway, St Leonards, New South Wales 2065
Country 121514 0
Australia
Phone 121514 0
+61423641270
Fax 121514 0
Email 121514 0
[email protected]
Contact person for public queries
Name 121515 0
Maureen Hitschfeld
Address 121515 0
IQVIA Solutions Pty Ltd, Level 8, 201 Pacific Highway, St Leonards, New South Wales 2065
Country 121515 0
Australia
Phone 121515 0
+61423641270
Fax 121515 0
Email 121515 0
[email protected]
Contact person for scientific queries
Name 121516 0
Maureen Hitschfeld
Address 121516 0
IQVIA Solutions Pty Ltd, Level 8, 201 Pacific Highway, St Leonards, New South Wales 2065
Country 121516 0
Australia
Phone 121516 0
+61423641270
Fax 121516 0
Email 121516 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Just aggregated data will be made publicly available.


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.