CTRI/2015/01/005378Other未知
A cumulative skin irritation study evaluating the skin irritancy potential of topical analgesicVovilup spray containing a combination of diclofenac, menthol, methyl salicylate and linseedoil and comparing it with a marketed formulation-Iodex Ultragel.
GSK Consumer Healthcare0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- Other
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Healthy male or female volunteers aged atleast 18 years.
- •2. Good general, physical and mental health in the opinion of the investigator or
- •medically qualified designee:
- •a) No clinically significant and relevant abnormalities in medical history or upon
- •physical examination.
- •b) Absence of any condition that could affect the volunteerâ??s safety or wellbeing or
- •their ability to understand and follow study procedures and requirements.
- •3. Healthy volunteers who do not have excessive hair on the volar aspect of the
- •forearm(s).
- •4. Healthy volunteers should understand and be willing to fully comply with all study
- •procedures and restrictions.
- •5. Demonstrates understanding of the study and willingness to participate as evidenced
- •by voluntary written informed consent and has received a signed and dated copy of
- •the informed consent form.
- •6. Females of childbearing potential, using an effective contraceptive method for at least
- •one month before the beginning of the study, and willing to use throughout the study.
排除标准
- •1. Volunteers having recent history (within one year) of alcohol or other substance abuse
- •as determined by medical history.
- •2. Participation in another clinical study or receipt of an investigational drug within 30
- •days of the screening visit.
- •3. Previous participation in similar study with similar products.
- •4. Volunteer has any visible skin disease at the site of application that, in the opinion of
- •the investigator, will interfere with the skin assessments.
- •5. Volunteer has current or relevant previous history of serious, severe or unstable
- •physical or psychiatric illness, or medical disorders, such as current or previous
- •history of hepatic or renal diseases (impairment) or peptic ulcer as determined by
- •medical history.
- •6. Volunteer has a history of hypersensitivity (e.g. asthma, bronchospasm, rhinitis,
- •urticaria, nasal polyps) to aspirin, diclofenac, other NSAIDs, menthol or any of the
- •excipients in the test product(s).
- •7. Volunteer is receiving systemic or topical NSAIDs, other oral or topical analgesics or
- •antihistamine within 3 days of visit 1, or other medication (such as corticosteroid
- •within 3 weeks of visit 1) which, in the opinion of the investigative personnel, will
- •interfere with the study results.
- •8. Female volunteers who are pregnant, planning to become pregnant during the study,
- •or are breast-feeding.
- •9. Female volunteers who have positive pregnancy test.
- •10. Volunteers who are employees of the sponsor or study site or an immediate family
- •member (e.g. partner, offspring, parents, siblings or siblingâ??s offspring) of such
- •11. Any skin disorder at the test site that in the investigatorâ??s judgement can affect the
- •readings of the test result
- •12. Any concomitant medications that in the investigatorâ??s judgement can confound or
- •alter test results or evaluation of adverse events.
研究者
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