A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of scalp cream for Symptom Relief and Microbiome Balance in mild-moderate Seborrheic Dermatitis patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- 1. To evaluate the effectiveness of the test treatments by assessing the change in Adherent Scalp Flaking Score (ASFS) from baseline, both within treatment group and between treatment groups.
研究概览
简要总结
A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the safety and efficacy of scalp cream for Symptom Relief and Microbiome Balance in mild-moderate Seborrheic Dermatitis patients. A total of 34 participants, including males and non-pregnant, non-lactating females aged between 20 and 55 years (inclusive) with a confirmed diagnosis of mild to moderate seborrheic dermatitis, will be enrolled in the study.
- Visit 01(Within 15 Days): Screening, ICD obtained.
- Visit 02 (Day 1): Enrolment, Baseline Evaluations, Treatment Usage, Post Treatment Usage Evaluations at 30 mins (T30 Mins).
- Visit 03 (Day 30 +2 Days): Post-usage evaluation
- Visit 04 (Day 60 +2 Days): Post-usage evaluation and End of Study.
- Telephonic Follow Up (Day 90 + 2 Days)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 20-55 years (both inclusive) at the time of consent.
- •Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
- •Females of childbearing potential must have a self-reported negative urine pregnancy.
- •Subject is in good general health as determined by the Investigator on the basis of medical history.
- •Patients must have a confirmed diagnosis of mild to moderate scalp seborrheic dermatitis, with an ASFS score of at least 16 at the time of screening.
- •The severity grade will be evaluated by the dermatologist using the ASFS scale during the clinical study.
- •Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
- •If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence).
- •Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
- •Patients who commit not to use any other medicated/ prescription shampoos/hair care products, any other hair growth products or hair colour or dye, other than the test treatment for the entire duration of the study.
- •Patients who are having refrigerator at their home for storage of test treatment.
- •Subject is willing and able to comply with study procedures, including all scheduled visits, treatment applications, and assessments.
- •Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
- •Subject must be able to understand and provide written informed consent to participate in the study.
排除标准
- •Subject with known allergy or sensitization to test treatment ingredients.
- •Subjects with a history of dermatological scalp conditions other than seborrheic dermatitis or dandruff (e.g., psoriasis, tinea capitis, lichen planopilaris) .
- •Subject who had taken topical treatment of dandruff for at least 4 weeks.
- •Subject who had taken any systemic treatment for at least 3 months.
- •Subject who have plans of shaving scalp hair during the study.
- •Use of systemic or topical medications (e.g., corticosteroids, immunosuppressants, retinoids) known to affect skin or scalp within the past 3 months, or any medical history likely to interfere with study.
- •Subject has any concurrent skin disease.
- •History of alcohol or drug addiction.
- •Subjects with an allergy to dairy products.
- •Subjects with a history or current presentation of visibly inflamed, infected, or severely irritated scalp, or known sensitivity to topical or cosmetic products.
- •Pregnant or breast feeding or planning to become pregnant during the study period.
- •Use of antibiotics, antifungal medications, or oral/topical probiotics within the past 4 weeks 13) History of chronic illness which may influence the cutaneous state.
- •Subject have participated any clinical research study related to hair care products within past 3 months.
结局指标
主要结局
1. To evaluate the effectiveness of the test treatments by assessing the change in Adherent Scalp Flaking Score (ASFS) from baseline, both within treatment group and between treatment groups.
时间窗: 1. To evaluate the effectiveness of the test treatments by assessing the change in Adherent Scalp Flaking Score (ASFS) from baseline on Day 01 and post usage of test treatment on Day 30 (+2 Days), Day 60 (+2 Days) and between treatment groups using ASFS scale. | 2. To evaluate the effectiveness of the test treatment by assessing the change in flake coverage using CASLiteNova from 8 parts of the scalp from baseline on Day 01 and post usage of test treatment on Day 30 (+2 Days), Day 60 (+2 Days) and between treatment groups. | 3. To evaluate the effectiveness of the test treatment by assessing reduction in itching from baseline on Day 01 and post usage of test treatment at T30 mins on Day 01, Day 30 (+2 Days), Day 60 (+2 Days) and between treatment groups using VAS scale for itching. | 4. To evaluate the effectiveness of test treatment by assessing change in erythema Index using Mexameter® MX 18 and by Dermatologist and Dermatologist trained evaluator from baseline on Day 01 and post usage of test treatment at T30 mins on Day 01, Day 30 (+2 Days), Day 60 (+2 Days) and between treatment groups.
2. To evaluate the effectiveness of the test treatment by assessing the change in flake coverage for quantification of adherent flakes from baseline, both within treatment group and between treatment groups.
时间窗: 1. To evaluate the effectiveness of the test treatments by assessing the change in Adherent Scalp Flaking Score (ASFS) from baseline on Day 01 and post usage of test treatment on Day 30 (+2 Days), Day 60 (+2 Days) and between treatment groups using ASFS scale. | 2. To evaluate the effectiveness of the test treatment by assessing the change in flake coverage using CASLiteNova from 8 parts of the scalp from baseline on Day 01 and post usage of test treatment on Day 30 (+2 Days), Day 60 (+2 Days) and between treatment groups. | 3. To evaluate the effectiveness of the test treatment by assessing reduction in itching from baseline on Day 01 and post usage of test treatment at T30 mins on Day 01, Day 30 (+2 Days), Day 60 (+2 Days) and between treatment groups using VAS scale for itching. | 4. To evaluate the effectiveness of test treatment by assessing change in erythema Index using Mexameter® MX 18 and by Dermatologist and Dermatologist trained evaluator from baseline on Day 01 and post usage of test treatment at T30 mins on Day 01, Day 30 (+2 Days), Day 60 (+2 Days) and between treatment groups.
3. To evaluate the effectiveness of the test treatment by assessing reduction in itching from baseline, both within treatment group and between treatment groups.
时间窗: 1. To evaluate the effectiveness of the test treatments by assessing the change in Adherent Scalp Flaking Score (ASFS) from baseline on Day 01 and post usage of test treatment on Day 30 (+2 Days), Day 60 (+2 Days) and between treatment groups using ASFS scale. | 2. To evaluate the effectiveness of the test treatment by assessing the change in flake coverage using CASLiteNova from 8 parts of the scalp from baseline on Day 01 and post usage of test treatment on Day 30 (+2 Days), Day 60 (+2 Days) and between treatment groups. | 3. To evaluate the effectiveness of the test treatment by assessing reduction in itching from baseline on Day 01 and post usage of test treatment at T30 mins on Day 01, Day 30 (+2 Days), Day 60 (+2 Days) and between treatment groups using VAS scale for itching. | 4. To evaluate the effectiveness of test treatment by assessing change in erythema Index using Mexameter® MX 18 and by Dermatologist and Dermatologist trained evaluator from baseline on Day 01 and post usage of test treatment at T30 mins on Day 01, Day 30 (+2 Days), Day 60 (+2 Days) and between treatment groups.
4. To evaluate the effectiveness of the test treatment by assessing change in Scalp Erythema Index from baseline, both within treatment group and between treatment groups
时间窗: 1. To evaluate the effectiveness of the test treatments by assessing the change in Adherent Scalp Flaking Score (ASFS) from baseline on Day 01 and post usage of test treatment on Day 30 (+2 Days), Day 60 (+2 Days) and between treatment groups using ASFS scale. | 2. To evaluate the effectiveness of the test treatment by assessing the change in flake coverage using CASLiteNova from 8 parts of the scalp from baseline on Day 01 and post usage of test treatment on Day 30 (+2 Days), Day 60 (+2 Days) and between treatment groups. | 3. To evaluate the effectiveness of the test treatment by assessing reduction in itching from baseline on Day 01 and post usage of test treatment at T30 mins on Day 01, Day 30 (+2 Days), Day 60 (+2 Days) and between treatment groups using VAS scale for itching. | 4. To evaluate the effectiveness of test treatment by assessing change in erythema Index using Mexameter® MX 18 and by Dermatologist and Dermatologist trained evaluator from baseline on Day 01 and post usage of test treatment at T30 mins on Day 01, Day 30 (+2 Days), Day 60 (+2 Days) and between treatment groups.
次要结局
- To evaluate the effectiveness of the test treatment by assessing change in scalp microbiome from baseline, both within treatment group and between treatment groups.(Evaluations will be done at three time points on Day 01, Day 30, Day 60)
- To evaluate the effectiveness of the test treatment by assessing change in scalp barrier function from baseline, both within treatment group and between treatment groups.(Evaluation will be done at four time points at baseline on Day 01 and at T30 mins of Day 01, Day 30 and Day 60)
- To evaluate the effectiveness of the test treatment by assessing change in sebum production from baseline, both within treatment group and between treatment groups.(Evaluation will be done at four time points at baseline on Day 01 and at T30 mins of Day 01, Day 30 and Day 60)
- To evaluate the effectiveness of the test treatment by assessing reduction in hair fall and non-adherent flake count from baseline, both within treatment group and between treatment groups.(Evaluations will be done at three time points on Day 01, Day 30, Day 60)
- To evaluate the effectiveness of the test treatment by assessing change in general appearance of scalp from baseline, both within treatment group and between treatment groups.(Evaluation will be done at four time points at baseline on Day 01 and at T30 mins of Day 01, Day 30 and Day 60)
- To evaluate the effectiveness of test treatment by assessing change in hair density and hair thickness from baseline, both within treatment group and between treatment groups.(Evaluations will be done at three time points on Day 01, Day 30, Day 60)
- To evaluate the effectiveness of the test treatment by assessing treatment perception questionnaire through Quality-of-Life Questionnaire by using 5-point Likert scale and PGIC questionnaire from baseline, both within treatment group and between treatment groups.(Evaluation will be done at four time points at baseline on Day 01 and at T30 mins of Day 01, Day 30 and Day 60)
研究者
Dr Alka Makwana
NovoBliss Research Private Limited