PainPhase 1NCT02169154
A Safety Study to Investigate the Skin Irritancy Potential of Diclofenac-Menthol Gel
A Phase 1 study testing 1% Diclofenac Sodium, 3% Menthol and 0.09% Menthol in people with Pain, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This research study is being conducted to investigate the skin irritancy potential of a new medication which contains two active ingredients (diclofenac and menthol) together in a gel formulation and is being developed to treat mild to moderate pain and inflammation, such as acute sport injuries, sprains and strains. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- 1% Diclofenac Sodium, 3% Menthol and 0.09% Menthol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2014to 1 Jul 2014
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male/female volunteer ≥18 years
- No systemic/dermatologic disorder
Who cannot join
- Visible skin disease at the site of application that might interfere with skin assessments
- Allergy or hypersensitivity to NSAIDs or menthol or any of the excipients in the test product
- History of physical or psychiatric illness, or medical disorder
- Recent history of alcohol or drug abuse
- Pregnant or lactating females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cumulative Skin Irritation Study Investigating the Skin Irritancy Potential of MFC51123 Diclofenac-Menthol Gel
This research study is being conducted to investigate the skin irritancy potential of a new medication which contains two active ingredients (diclofenac and menthol) together in a gel formulation and is being developed to treat mild to moderate pain and inflammation, such as acute sport injuries, sprains and strains.
Read the detailed description
Approximately 36 healthy subject volunteers will be exposed to seven test products (study treatment gel and six control products) simultaneously for 21 consecutive days. The seven test products will be applied using a 7-channel patch assembly that will be affixed to the infrascapular areas of the back of each subject for approximately 24 hours daily.
The subject will return to the clinic to undergo a skin irritation assessment at approximately 24 hours after the time the patch assembly was initially affixed.
During the visits, doctors or trained staff members will examine the signs of irritation (if any) of the skin where the test products are applied. The skin irritation assessment will primarily characterize the test products individually in terms of symptomatology using a 7-point categorical scale ranging from 1 (glazing and/or wrinkling) to 7 (erosion and/or vesiculation).
- Conditions
- Pain
- Being tested
- 1% Diclofenac Sodium, 3% Menthol, 0.09% Menthol, 0.2% Sodium Lauryl Sulfate, 0.9% Saline
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% Diclofenac SodiumDrug
1% diclofenac sodium
3% MentholDrug
3% Menthol
0.09% MentholDrug
0.09% Menthol
0.2% Sodium Lauryl SulfateDrug
0.2% Sodium Lauryl Sulfate
0.9% SalineDrug
0.9% Saline
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac Sodium/Menthol Gel | Experimental | 1% diclofenac sodium + 3% menthol Receives: Drug: 1% Diclofenac Sodium; Drug: 3% Menthol |
| Diclofenac Gel | Active comparator | 1% diclofenac sodium + 0.09% menthol Receives: Drug: 1% Diclofenac Sodium; Drug: 0.09% Menthol |
| Menthol Gel | Active comparator | 3% menthol Receives: Drug: 3% Menthol |
| Placebo Gel | Placebo comparator | 0.09% menthol Receives: Drug: 0.09% Menthol |
| Voltaren Gel | Active comparator | 1% diclofenac sodium Receives: Drug: 1% Diclofenac Sodium |
| Sodium lauryl sulfate | Placebo comparator | 0.2% Sodium lauryl sulfate Receives: Drug: 0.2% Sodium Lauryl Sulfate |
| Saline | Placebo comparator | 0.9% saline Receives: Drug: 0.9% Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment mean cumulative irritation score
Cumulative irritation scores will be defined daily as the sum of irritation score and grade number
Measured: Day 21
Adverse event assessment
Adverse events will be graded on a three-point scale: 1. Mild-easily tolerated, causing minimal discomfort and not interfering with normal everyday activities; 2. Moderate-sufficiently discomforting to interfere with normal everyday activities; 3. Severe-any event that prevents normal everyday activities
Measured: 21 days + 5 days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study start1 Jun 2014
- Primary completion1 Jul 2014
- Study completion1 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 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
- NCT02169154
- Sponsor's protocol ID
- 202187
- Other IDs
- RH02170
- Status last verified
- Jun 2017
- First submitted
- 19 Jun 2014
- Last updated
- 29 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cumulative Skin Irritation Study Investigating the Skin Irritancy Potential of MFC51123 Diclofenac-Menthol Gel
- ClinicalTrials.gov ID
- NCT02169154
- Acronym / sponsor ID
- 202187
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 1 Jul 2014 (actual)
- Study completion
- 1 Jul 2014 (actual)
- First posted
- 23 Jun 2014 (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.
This research study is being conducted to investigate the skin irritancy potential of a new medication which contains two active ingredients (diclofenac and menthol) together in a gel formulation and is being developed to treat mild to moderate pain and inflammation, such as acute sport injuries, sprains and strains.
Detailed description
Approximately 36 healthy subject volunteers will be exposed to seven test products (study treatment gel and six control products) simultaneously for 21 consecutive days. The seven test products will be applied using a 7-channel patch assembly that will be affixed to the infrascapular areas of the back of each subject for approximately 24 hours daily.
The subject will return to the clinic to undergo a skin irritation assessment at approximately 24 hours after the time the patch assembly was initially affixed.
During the visits, doctors or trained staff members will examine the signs of irritation (if any) of the skin where the test products are applied. The skin irritation assessment will primarily characterize the test products individually in terms of symptomatology using a 7-point categorical scale ranging from 1 (glazing and/or wrinkling) to 7 (erosion and/or vesiculation).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Diclofenac Sodium/Menthol Gel | Experimental | Drug: 1% Diclofenac Sodium, Drug: 3% Menthol1% diclofenac sodium + 3% menthol |
| Diclofenac Gel | Active comparator | Drug: 1% Diclofenac Sodium, Drug: 0.09% Menthol1% diclofenac sodium + 0.09% menthol |
| Menthol Gel | Active comparator | Drug: 3% Menthol3% menthol |
| Placebo Gel | Placebo comparator | Drug: 0.09% Menthol0.09% menthol |
| Voltaren Gel | Active comparator | Drug: 1% Diclofenac Sodium1% diclofenac sodium |
| Sodium lauryl sulfate | Placebo comparator | Drug: 0.2% Sodium Lauryl Sulfate0.2% Sodium lauryl sulfate |
| Saline | Placebo comparator | Drug: 0.9% Saline0.9% saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male/female volunteer ≥18 years
- No systemic/dermatologic disorder
Key exclusion criteria (5 listed)
- Visible skin disease at the site of application that might interfere with skin assessments
- Allergy or hypersensitivity to NSAIDs or menthol or any of the excipients in the test product
- History of physical or psychiatric illness, or medical disorder
- Recent history of alcohol or drug abuse
- Pregnant or lactating females
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 |
|---|---|---|
| 1% Diclofenac Sodium1% diclofenac sodium | Drug | Diclofenac Gel, Diclofenac Sodium/Menthol Gel, Voltaren Gel |
| 3% Menthol3% Menthol | Drug | Diclofenac Sodium/Menthol Gel, Menthol Gel |
| 0.09% Menthol0.09% Menthol | Drug | Diclofenac Gel, Placebo Gel |
| 0.2% Sodium Lauryl Sulfate0.2% Sodium Lauryl Sulfate | Drug | Sodium lauryl sulfate |
| 0.9% Saline0.9% Saline | Drug | Saline |
Primary outcome
Treatment mean cumulative irritation score
Time frame: Day 21
Cumulative irritation scores will be defined daily as the sum of irritation score and grade number
Adverse event assessment
Time frame: 21 days + 5 days follow-up
Adverse events will be graded on a three-point scale: 1. Mild-easily tolerated, causing minimal discomfort and not interfering with normal everyday activities; 2. Moderate-sufficiently discomforting to interfere with normal everyday activities; 3. Severe-any event that prevents normal everyday activities
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
- Results for the study 202187 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 1% Diclofenac Sodium, 3% Menthol and 0.09% Menthol in people with Pain, run by GlaxoSmithKline at 1 site in United States.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment mean cumulative irritation score (time frame: Day 21). The study lists 2 primary outcomes in all. 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 29 Jun 2017.