A Real-World Observational Study to Evaluate the Effectiveness of Skin Care Products Containing Thymol and Terpineol in Treating Mild to Moderate Acne
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Change in the acne reduction from baseline
研究概览
简要总结
Acne vulgaris is a common skin disease that affects above 85% of people at some time during their lifetime. It is characterized as either non-inflammatory (open/black and closed/white comedones) or inflammatory (papules, pustules, nodules, and cysts), leading to scar development and pigmentation on the skin. These skin conditions affect the quality of life in multiple dimensions, including psychosocial consequences, such as anxiety and depression. Topical retinoids, benzoyl peroxide, salicylic acid, glycolic acid, azelaic acid, and combinations of topical agents are currently considered the first-line choice in acne management. Combining retinoids with other topical agents, procedures, and oral therapies is also recommended. The major limitations of these therapies are side effects, such as hypersensitivity reactions and cutaneous irritation at the application site.
Novology leverages the patented TT2 Technology which is a synergistic combination of thymol–terpineol (TT) in the Acne products. TT2 technology-based formulations are hypoallergenic, suitable for sensitive skin, and help in reducing acne with minimum irritation at the application site which is the limitation of topical retinoids. This combination inhibits and targets the acne-causing bacteria (C acnes) while rebalancing the microbiome, which are essential for regulating our skin’s health.
This study is a real-world, observational, multicentric clinical study of 0.1% thymol + terpineol (Serum) and 0.35% thymol + terpineol (Cleanser) (acne serum vs cleanser) in the reduction of mild-to-moderate acne lesions. The cleanser or serum will have to be applied on the face for 8 weeks (56 days). Study visits will consist of screening and follow-up visits on Day 1, Day 7 ± 2 days, Day 14 ± 2 days, Day 28 ± 2 days, and Day 56 ± 2 days.
The Primary objective is To evaluate the effectiveness of acne serum and acne cleanser together and acne serum alone on inflammatory/non-inflammatory acne lesions on the face of subjects with mild-to-moderate acne.
Dermatological assessments, subjects’ self-assessment questionnaire, Acne-QoL questionnaire, and subjects’ perception of the product will be assessed. Safety events if any reported by subjects will be recorded. The results of the Study will be published in a peer-reviewed international journal. In accordance with the Declaration of Helsinki, both authors and publishers have ethical obligations.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects who meet all of the following criteria will be included in the study.
- •Indian subjects (20% male and 80% female subjects) with mild-to-moderate acne, from more than or equal to 18 years to less than or equal to 40 years of age at the time of consent.
- •Subjects with mild to moderate acne condition (Grade 2 to 3 as per Investigator Global Assessment [IGA] scale).
- •Subjects with normal Fitzpatrick skin type III to VI (human skin color determination scale).
- •Subjects who have been prescribed either the 0.1% thymol + terpineol (Serum) or 0.35% thymol + terpineol (Cleanser) for acne treatment as per the investigator discretion will be invited to participate in the study and provide their data, with no changes to the prescribed treatment.
- •Subjects are able to follow their normal skin routines and refrain from introducing any similar skin care products for acne during the study.
- •Subjects are willing to give written informed consent and are willing to comply with the study protocol.
排除标准
- •Subject has a history of allergy or sensitivity to the study product ingredients.
- •Subjects with severe acne conditions, i.e. cysts, and/or nodules, as determined by the investigator/treating doctor.
- •Subjects who have pre-existing or dormant dermatologic conditions (e.g. psoriasis rashes, eczema, seborrheic dermatitis, or any other) that could interfere with the outcome of the study as determined by the investigator.
- •Subject has used any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks before the start or anticipates having to use at any point during the study.
- •Pregnant or lactating females or planning to become pregnant during the study period.
- •Subjects participating in other similar cosmetics, devices, therapeutic trials, or skin care products within the last 4 weeks.
结局指标
主要结局
Change in the acne reduction from baseline
时间窗: Day 1 to days 7, 14, 28, and 56 using the IGA scale.
次要结局
- 1)Change in post inflammatory hyperpigmentation using PIH scale.(2)Change in post acne hyperpigmentation using PAH scale.)
研究者
Dr Anil K V Minz
Genesis Skin Clinic,Faridabad