ACTRN12622001202752已完成未知
Investigating the effect of Swisse's acne support product on the incidence of inflammatory skin lesions in young adults
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 211
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 30 Years（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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;
研究者
相似试验
已完成
不适用
To study the reduction in pimples.CTRI/2022/06/043346CLAIMS PVTLTD12
尚未招募
不适用
Evaluation of skin care products for Chinese having consciousness of sensitive skiHealthy adultsJPRN-UMIN000038383Consumer Behaivor Research CORP60
已完成
不适用
Cosmetic Study to Improve the Appearance of Skin Afflicted With Mild to Moderate Atopic Dermatitis.Atopic Dermatitis EczemaNCT03268174AOBiome LLC19
尚未招募
1 期
Assess effectiveness of Helfer Skin Tap on pain associated with intramuscular injection Benzathine pencillin in Rheumatic Heart disease patientCTRI/2018/12/016745Maj Shanti Jakhwal
已完成
不适用
Verification of skin condition improvement effect by intake of fermented food of lactic acid bacterium N320 straiHealthy adultsJPRN-UMIN000030349Shiba Palace Clinic60