Skin IrritationPhase 4NCT02400320
Local Skin Safety Study of a Topical Pain Relief Spray Containing a Combination of Diclofenac, Methyl Salicylate, and Menthol
A Phase 4 study testing Topical Spray, Topical Gel and Saline in people with Skin Irritation, run by GlaxoSmithKline.
Trial summary
The purpose of this study is to determine local skin safety of a topical analgesic spray containing a combination of diclofenac, methyl salicylate, menthol and compare it with a topical analgesic gel containing a combination of diclofenac, methyl salicylate, and menthol. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Irritation
- What is being tested?
- Topical Spray, Topical Gel and Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 30 Jun 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female volunteers aged at least 18 years.
- Good general, physical and mental health in the opinion of the investigator or medically qualified designee:
- No clinically significant and relevant abnormalities in medical history or upon physical examination.
- Absence of any condition that could affect the volunteer's safety or well being or their ability to understand and follow study procedures and requirements.
- Healthy volunteers who do not have excessive hair on the volar aspect of the forearm(s).
- Healthy volunteers should understand and be willing to fully comply with all study procedures and restrictions.
- 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.
- 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
Who cannot join
- Volunteers having recent history (within one year) of alcohol or other substance abuse as determined by medical history.
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- Previous participation in similar study with similar products.
- Volunteer has any visible skin disease at the site of application that, in the opinion of the investigator, will interfere with the skin assessments.
- 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.
- Volunteer has a history of hypersensitivity (e.g. asthma, bronchospasm, rhinitis, urticaria, nasal polyps) to aspirin, diclofenac, other non steroidal anti-inflammatory drugs (NSAIDs), menthol or any of the excipients in the test product(s).
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- 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 corticosteroids within 3 weeks of visit 1) which, in the opinion of the investigative personnel, will interfere with the study results.
- Female volunteers who are pregnant, planning to become pregnant during the study, or are breast-feeding.
- Female volunteers who have positive pregnancy test.
- Volunteers who are employees of the sponsor or study site or an immediate family member (e.g. partner, offspring, parents, siblings or sibling's offspring) of such employees.
- Any skin disorder at the test site that in the investigator's judgement can affect the readings of the test result
- Any concomitant medications that in the investigator's judgement can confound or alter test results or evaluation of adverse events.
About this study
Official title: Cumulative Skin Irritation Study Evaluating the Skin Irritancy Potential of Topical Analgesic Vovilup Spray Containing a Combination of Diclofenac, Menthol, Methyl Salicylate and Linseed Oil and Comparing it With a Marketed Formulation - Iodex Ultragel
The purpose of this study is to determine local skin safety of a topical analgesic spray containing a combination of diclofenac, methyl salicylate, menthol and compare it with a topical analgesic gel containing a combination of diclofenac, methyl salicylate, and menthol.
- Conditions
- Skin Irritation
- Being tested
- Topical Spray, Topical Gel, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical SprayDrug
Topical spray containing Diclofenac 1.16%, Linseed Oil 3%, Menthol 5%, Methyl salicylate 10%.
Topical GelDrug
Topical gel containing Diclofenac 1.16%, Menthol 5%, Methyl salicylate 10%
SalineOther
Saline
| Study group | Role | What they receive |
|---|---|---|
| Topical Spray | Active comparator | Topical spray containing Diclofenac 1.16%, Linseed Oil 3%, Menthol 5%, Methyl salicylate 10%. Receives: Drug: Topical Spray |
| Topical Gel | Experimental | Topical gel containing Diclofenac 1.16%, Menthol 5%, Methyl salicylate 10% Receives: Drug: Topical Gel |
| Saline | Other | Saline Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean cumulative irritation score
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study start1 Mar 2016 (estimated)
- Primary completion1 Jun 2016 (estimated)
- Study completion30 Jun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin IrritationStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400320
- Sponsor's protocol ID
- 202201
- Status last verified
- Sep 2017
- First submitted
- 29 Jan 2015
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cumulative Skin Irritation Study Evaluating the Skin Irritancy Potential of Topical Analgesic Vovilup Spray Containing a Combination of Diclofenac, Menthol, Methyl Salicylate and Linseed Oil and Comparing it With a Marketed Formulation - Iodex Ultragel
- ClinicalTrials.gov ID
- NCT02400320
- Acronym / sponsor ID
- 202201
- Conditions
- Skin Irritation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2016 (estimated)
- Primary completion
- 1 Jun 2016 (estimated)
- Study completion
- 30 Jun 2016 (estimated)
- First posted
- 27 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine local skin safety of a topical analgesic spray containing a combination of diclofenac, methyl salicylate, menthol and compare it with a topical analgesic gel containing a combination of diclofenac, methyl salicylate, and menthol.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Topical Spray | Active comparator | Drug: Topical SprayTopical spray containing Diclofenac 1.16%, Linseed Oil 3%, Menthol 5%, Methyl salicylate 10%. |
| Topical Gel | Experimental | Drug: Topical GelTopical gel containing Diclofenac 1.16%, Menthol 5%, Methyl salicylate 10% |
| Saline | Other | Other: SalineSaline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy male or female volunteers aged at least 18 years.
- Good general, physical and mental health in the opinion of the investigator or medically qualified designee:
- Healthy volunteers who do not have excessive hair on the volar aspect of the forearm(s).
- Healthy volunteers should understand and be willing to fully comply with all study procedures and restrictions.
- 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.
Key exclusion criteria (12 listed)
- Volunteers having recent history (within one year) of alcohol or other substance abuse as determined by medical history.
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- Previous participation in similar study with similar products.
- Volunteer has any visible skin disease at the site of application that, in the opinion of the investigator, will interfere with the skin assessments.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical SprayTopical spray containing Diclofenac 1.16%, Linseed Oil 3%, Menthol 5%, Methyl salicylate 10%. | Drug | Topical Spray |
| Topical GelTopical gel containing Diclofenac 1.16%, Menthol 5%, Methyl salicylate 10% | Drug | Topical Gel |
| SalineSaline | Other | Saline |
Primary outcome
Mean cumulative irritation score
Time frame: 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topical Spray, Topical Gel and Saline in people with Skin Irritation, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean cumulative irritation score (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2017.