A clinical study to determine the skin irritancy potential of a topical analgesicVovilup spray and comparing it with a marketed formulation-Iodex Ultragel. it with the other product
- Registration Number
- CTRI/2015/01/005378
- Lead Sponsor
- GSK Consumer Healthcare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
employees.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method