None listed
Conditions
Brief summary
This study involves the testing for eight weeks of a regulatory approved acne support supplement The research project is aiming to: • generate evidence-based advertising claims within the regulatory-permitted indications for the Acne Support product. • evaluate the product effectiveness on acne severity will be evaluated in an eight-week real-life direct-to participant setting, in people with mild-to-moderate facial acne. • assess the effectiveness of the treatment on other outcomes related to the condition and participants’ quality of life Patients will be recruited via a consumer panel or through social media or other virtual channels via an online screening survey. This study will be completed taking one oral tablet of the Acne Support product once daily for eight weeks.
Interventions
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-lis
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
Sponsors
Swisse Wellness Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 30 Years
Healthy volunteers
No
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.
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;
Outcome results
None listed