PainPhase 1NCT02192203
A Safety Study to Investigate the Skin Sensitization Potential of MFC51123
A Phase 1 study testing Diclofenac + Menthol Gel, Diclofenac Only Gel and Menthol Only Gel in people with Pain, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This research study is being carried out to determine the possibility that a new medication causes allergic reactions. This new medication contains two active ingredients (diclofenac and menthol) together in a gel and is being developed to treat mild to moderate pain and inflammation, such as acute sport injuries, and… 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?
- Diclofenac + Menthol Gel, Diclofenac Only Gel and Menthol Only Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 227 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2014to 15 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
- Healthy men or women participants with 18 years of age or older.
Who cannot join
- Participants with a history of hypersensitivity, allergy with the use of NSAIDs or menthol or currently receiving systemic or topical NSAIDs within 3 days of visit 1.
- Participants having psoriasis and/or active atopic dermatitis/eczema, and skin infected.
- Lesions, burn or wound in the application site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety Study to Investigate the Skin Sensitization Potential of MFC51123
This research study is being carried out to determine the possibility that a new medication causes allergic reactions. This new medication contains two active ingredients (diclofenac and menthol) together in a gel and is being developed to treat mild to moderate pain and inflammation, such as acute sport injuries, and sprains and strains. Approximately 240 participants will have the medication (gel) applied to the skin on a small area of the upper back for approximately 48-hour or 72-hour periods over the course of six weeks. Participation in this research study is voluntary, requiring participants to visit the study clinic on 17 occasions for about 45 minutes each visit. During the visits, doctors or trained staff members will examine the amount of redness, swelling, and other signs of irritation (if any) of the skin where the medication (gel) was applied.
- Conditions
- Pain
- Being tested
- Diclofenac + Menthol Gel, Diclofenac Only Gel, Menthol Only Gel, Placebo Only Gel
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac + Menthol GelDrug
1% diclofenac, 3% menthol
Diclofenac Only GelDrug
1% diclofenac, 0.09% menthol
Menthol Only GelDrug
3% menthol
Placebo Only GelDrug
0.09% menthol
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac + Menthol Gel | Experimental | 1% diclofenac, 3% menthol Receives: Drug: Diclofenac + Menthol Gel |
| Diclofenac Only Gel | Active comparator | 1% diclofenac, 0.09% menthol Receives: Drug: Diclofenac Only Gel |
| Menthol Only Gel | Active comparator | 3% menthol Receives: Drug: Menthol Only Gel |
| Placebo Only Gel | Placebo comparator | 0.09% menthol Receives: Drug: Placebo Only Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin irritation
During the Induction Phase, the test article and three controls will be applied to adjacent treatment sites on the infrascapular area of the back for nine 48-hour patch applications. Evaluation of dermal reactions at the application sites will be conducted clinically using a visual scale that rates the degree of erythema, edema, and other signs of cutaneous irritation at nine intervals spaced approximately 48-72 hours apart. Following the Induction Phase participants will return to the clinic to begin the Challenge Phase after 12 to 14- day rest phase. The Challenge Phase will consist of one 48-hour patch application to a naive site on the opposite side of the back. Evaluations of dermal reactions at the application sites will be conducted clinically during the Challenge Phase using the same visual scale at 30 minutes, 24 hours, 48 hours, and 72 hours after removal of the challenge patch.
Measured: At least 23 days but not more than 30 days for induction and challenge phases combined
Secondary outcomes (2)
Effects on Superficial Layers of the Skin
The responses will be assessed using symbol (A-H) and grade (0 -3) scale for each of the four test products: A 0 Slight glazed appearance; C 1 Marked glazing; E 2 Glazing with peeling and cracking; F 3 Glazing with fissures; G 3 Film of dried serous exudate covering all or portion of the patch; H 3 Small petechial erosions and/or scabs
Measured: At least 23 days but not more than 30 days for induction and challenge phases combined
Response notation
Notations will be made in place of a score to designate particular circumstances preventing the assignment of a score or in addition to a score to identify damage to the epidermis and/or spreading of a reaction beyond the patch site.S: Spreading of reaction beyond patch study site (i.e., reaction where study material was not in contact with the skin); B: Burning or stinging sensation; P: Papular response >50%; Pv: Papulovesicular response >50%; D: Damage to epidermis: oozing, crusting and/or superficial erosions; I; Itching; X: absent Subject absent; PD: Patch dislodged; NA Not applied; NP: Not patched (due to reaction achieved); N9G: No ninth grading
Measured: At least 23 days but not more than 30 days for induction and challenge phases combined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study start1 Apr 2014
- Primary completion15 Jul 2014
- Study completion15 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 227 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
- NCT02192203
- Sponsor's protocol ID
- 202186
- Other IDs
- RH02169
- Status last verified
- Jun 2017
- First submitted
- 15 May 2014
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study to Investigate the Skin Sensitization Potential of MFC51123
- ClinicalTrials.gov ID
- NCT02192203
- Acronym / sponsor ID
- 202186
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 15 Jul 2014 (actual)
- Study completion
- 15 Jul 2014 (actual)
- First posted
- 16 Jul 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 carried out to determine the possibility that a new medication causes allergic reactions. This new medication contains two active ingredients (diclofenac and menthol) together in a gel and is being developed to treat mild to moderate pain and inflammation, such as acute sport injuries, and sprains and strains. Approximately 240 participants will have the medication (gel) applied to the skin on a small area of the upper back for approximately 48-hour or 72-hour periods over the course of six weeks. Participation in this research study is voluntary, requiring participants to visit the study clinic on 17 occasions for about 45 minutes each visit. During the visits, doctors or trained staff members will examine the amount of redness, swelling, and other signs of irritation (if any) of the skin where the medication (gel) was applied.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Diclofenac + Menthol Gel | Experimental | Drug: Diclofenac + Menthol Gel1% diclofenac, 3% menthol |
| Diclofenac Only Gel | Active comparator | Drug: Diclofenac Only Gel1% diclofenac, 0.09% menthol |
| Menthol Only Gel | Active comparator | Drug: Menthol Only Gel3% menthol |
| Placebo Only Gel | Placebo comparator | Drug: Placebo Only Gel0.09% menthol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy men or women participants with 18 years of age or older.
Key exclusion criteria (3 listed)
- Participants with a history of hypersensitivity, allergy with the use of NSAIDs or menthol or currently receiving systemic or topical NSAIDs within 3 days of visit 1.
- Participants having psoriasis and/or active atopic dermatitis/eczema, and skin infected.
- Lesions, burn or wound in the application site.
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 |
|---|---|---|
| Diclofenac + Menthol Gel1% diclofenac, 3% menthol | Drug | Diclofenac + Menthol Gel |
| Diclofenac Only Gel1% diclofenac, 0.09% menthol | Drug | Diclofenac Only Gel |
| Menthol Only Gel3% menthol | Drug | Menthol Only Gel |
| Placebo Only Gel0.09% menthol | Drug | Placebo Only Gel |
Primary outcome
Skin irritation
Time frame: At least 23 days but not more than 30 days for induction and challenge phases combined
During the Induction Phase, the test article and three controls will be applied to adjacent treatment sites on the infrascapular area of the back for nine 48-hour patch applications. Evaluation of dermal reactions at the application sites will be conducted clinically using a visual scale that rates the degree of erythema, edema, and other signs of cutaneous irritation at nine intervals spaced approximately 48-72 hours apart. Following the Induction Phase participants will return to the clinic to begin the Challenge Phase after 12 to 14- day rest phase. The Challenge Phase will consist of one 48-hour patch application to a naive site on the opposite side of the back. Evaluations of dermal reactions at the application sites will be conducted clinically during the Challenge Phase using the same visual scale at 30 minutes, 24 hours, 48 hours, and 72 hours after removal of the challenge patch.
2 secondary outcomes
Effects on Superficial Layers of the Skin
Time frame: At least 23 days but not more than 30 days for induction and challenge phases combined
Response notation
Time frame: At least 23 days but not more than 30 days for induction and challenge phases combined
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 28 Jun 2017.
- Results for the study 202186 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 Diclofenac + Menthol Gel, Diclofenac Only Gel and Menthol Only Gel 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 1 inclusion and 3 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 28 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?
Skin irritation (time frame: At least 23 days but not more than 30 days for induction and challenge phases combined). 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 28 Jun 2017.