CTRI/2024/10/074925暂停不适用
A monocentric open label study to evaluate safety and efficacy of ciclopirox shampoo (8X shampoo) in males and females with scalp seborrhoeic dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- CIPLA LTD
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The outcome of the study is to determine whether the study product, when used twice daily for 28 days, is effective in preventing the recurrence of scalp seborrheic dermatitis.
研究概览
简要总结
Study Population:
- Number of Subjects: 30
- Demographics: males and females with SSD (Scalp Seborrheic Dermatitis)
- Age Range: 18 to 45 years
Completion Goal:
- Expected Completers: 25 subjects
Study Visits:
-
- Visit 1: Screening visit (Day -7 to Day -1)
- Visit 2: Baseline (D0) (Timepoints: T0 and T30 mins).
- Visit 3: Evaluation visit (Day 5)
- Visit 4: Evaluation visit (Day 13)
- Visit 5: Evaluation visit (Day 21)
- Visit 6: End of study (Day 28 + 1)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1Healthy Male and female participants at 18-45 years of age with mild to moderate SSD.
- •2Participants willing and capable of following the study rules, requirements and fixed schedule.
- •3Female participants who have a negative pregnancy test as verified by urine pregnancy test to be done on baseline visit (Day 0) and agree to use acceptable methods of contraception for the duration of the study.
- •4Participants who can understand, read and write the study documents (in their preferred language) and are willing to give the written informed consent.
- •5Participants agreeing to use only the investigational product on the scalp provided by centre throughout the study duration 6Participants agree not to use any other shampoos, conditioners, oils, serums, hair treatments, hair procedures, or other hair products during the study duration.
排除标准
- •1.Participants not matching one of the above-described eligibility criteria.
- •2.Participants are either pregnant or breast feeding or planning to get pregnant during the study period.
- •3.Participants who have started, stopped or changed his/her hormonal treatment (including contraceptive pill) in the previous one month or prior to the study.
- •4.Participants with any medical condition that, in the opinion of the Investigator, would jeopardize the health of the patient during the course of this study.
- •5.Known allergies to cosmetics and ingredients of test products.
- •6.Participants undergoing any topical or systemic treatment that could interfere with the study treatments/assessments (anti-seborrheic products, antibiotics, corticosteroids, retinoids, antiinflammatory drugs) taken within the last 4 weeks prior to participation in the study, and during the study.
- •7.Participants under any topical and/or systemic medications, such as anti-fungal medications, corticosteroids or immunosuppressive medications, NSAIDs, antihistamines, etc., that may interfere with the efficacy or safety assessment of the test product.
- •8.Participants with severe disorders within the last 6 months, e.g. cancer, circulatory disorders, serious diabetes or other scalp conditions that, in the Investigators judgment, may interfere with the study procedure.
- •9.Participants who are intellectual/ mental inability to follow study instructions (if suspected) or incapacitation.
- •10.Participants having participated in the last 30 days before screening or currently participating in another clinical study.
- •11.Participant who are unable to contacted by phone in case of emergency.
结局指标
主要结局
The outcome of the study is to determine whether the study product, when used twice daily for 28 days, is effective in preventing the recurrence of scalp seborrheic dermatitis.
时间窗: The outcome of the study is to determine whether the study product, when used twice daily for 28 days, is effective in preventing the recurrence of scalp seborrheic dermatitis.
次要结局
- To evaluate the effectiveness of the test product in improving the quality of life, assessed using the Scalpdex Questionnaire.(To evaluate the safety and cutaneous acceptability of the test product by monitoring local intolerances and adverse events through dermatologist assessments.)
研究者
Dr Pranami Kashyap
CIDP Biotech India Pvt Ltd
研究点 (1)
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