Healthy VolunteersPhase 1NCT02256930
Skin Safety Study to Evaluate the Sensitizing Potential in Healthy Volunteers
A Phase 1 study testing M518101, Sodium lauryl sulfate and Saline in people with Healthy Volunteers, run by Maruho North America Inc. at 1 site in United States.
Trial summary
This is a single center, randomized, controlled, within subject comparison, multiple dose study to determine the sensitization potential of M518101 on normal skin under occlusive patch condition. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- M518101, Sodium lauryl sulfate and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Aug 2015
- 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
- Health male or female subjects are age 18 years or older
- Signed and dated Informed Consent Form obtained prior to any study related activities
- Subjects are free of any systemic or dermatologic disorder
- For female, females of non childbearing potential or who agree to use a highly effective method of birth control during the study and have a negative urine pregnancy test
- Subjects must be able to communicate with the investigator and understand and comply with the requirement of the study and visit schedule
Who cannot join
- Have any visible skin disease at the application site which will interfere with the evaluation of the test site reaction
- Have damaged skin in or around the test sites
- Have a history of sensitivity to adhesive tape
- Have a known sensitivity to constituents present in the material being evaluated
- Have a history of, or are currently being treated for skin cancer
- Have used any study drug and/or participate in any clinical study within 60 days prior to randomization
Show all 9Show fewer
- To engage in any type of strenuous exercise
- Are pregnant, breastfeeding, or of childbearing potential and who wish to become pregnant during the study
- Are deemed to be ineligible by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Evaluator Blinded, Controlled Study to Evaluate the Sensitizing Potential of M518101 in Healthy Volunteers Using a Repeat Insult Patch Test Design
This is a single center, randomized, controlled, within subject comparison, multiple dose study to determine the sensitization potential of M518101 on normal skin under occlusive patch condition.
Read the detailed description
During the Induction Phase of the study, the study drugs and controls will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.
Following induction, subjects will have a 10 to 14-day Rest phase, after which they will enter the challenge Phase, which consists of one 48-hour patch application (occlusive) to a naïve site on the opposite side of the back.
- Conditions
- Healthy Volunteers
- Being tested
- M518101, M518101 Vehicle, Sodium lauryl sulfate, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M518101Drug
M518101 VehicleDrug
Sodium lauryl sulfateOther
SalineOther
| Study group | Role | What they receive |
|---|---|---|
| M518101 | Experimental | M518101 will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions. Receives: Drug: M518101 |
| M518101 Vehicle | Placebo comparator | M518101 Vehicle will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions. Receives: Drug: M518101 Vehicle |
| Sodium lauryl sulfate | Active comparator | The sodium lauryl sulfate will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions. Receives: Other: Sodium lauryl sulfate |
| Saline | Sham comparator | The saline will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions. Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
inflammatory skin response score
Drug application site will be evaluated for sign of inflammatory skin response (e.g. erythema, edema, papules)
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionNov 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maruho North America Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02256930
- Sponsor's protocol ID
- M518101-US07
- Status last verified
- Aug 2015
- First submitted
- 30 Sep 2014
- Last updated
- 11 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Evaluator Blinded, Controlled Study to Evaluate the Sensitizing Potential of M518101 in Healthy Volunteers Using a Repeat Insult Patch Test Design
- ClinicalTrials.gov ID
- NCT02256930
- Acronym / sponsor ID
- M518101-US07
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Maruho North America Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 6 Oct 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 is a single center, randomized, controlled, within subject comparison, multiple dose study to determine the sensitization potential of M518101 on normal skin under occlusive patch condition.
Detailed description
During the Induction Phase of the study, the study drugs and controls will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.
Following induction, subjects will have a 10 to 14-day Rest phase, after which they will enter the challenge Phase, which consists of one 48-hour patch application (occlusive) to a naïve site on the opposite side of the back.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| M518101 | Experimental | Drug: M518101M518101 will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions. |
| M518101 Vehicle | Placebo comparator | Drug: M518101 VehicleM518101 Vehicle will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions. |
| Sodium lauryl sulfate | Active comparator | Other: Sodium lauryl sulfateThe sodium lauryl sulfate will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions. |
| Saline | Sham comparator | Other: SalineThe saline will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Health male or female subjects are age 18 years or older
- Signed and dated Informed Consent Form obtained prior to any study related activities
- Subjects are free of any systemic or dermatologic disorder
- For female, females of non childbearing potential or who agree to use a highly effective method of birth control during the study and have a negative urine pregnancy test
- Subjects must be able to communicate with the investigator and understand and comply with the requirement of the study and visit schedule
Key exclusion criteria (9 listed)
- Have any visible skin disease at the application site which will interfere with the evaluation of the test site reaction
- Have damaged skin in or around the test sites
- Have a history of sensitivity to adhesive tape
- Have a known sensitivity to constituents present in the material being evaluated
- Have a history of, or are currently being treated for skin cancer
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 |
|---|---|---|
| M518101 | Drug | M518101 |
| M518101 Vehicle | Drug | M518101 Vehicle |
| Sodium lauryl sulfate | Other | Sodium lauryl sulfate |
| Saline | Other | Saline |
Primary outcome
inflammatory skin response score
Time frame: 21 days
Drug application site will be evaluated for sign of inflammatory skin response (e.g. erythema, edema, papules)
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 11 Aug 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 M518101, Sodium lauryl sulfate and Saline in people with Healthy Volunteers, run by Maruho North America Inc. 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 5 inclusion and 9 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 11 Aug 2015. 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?
inflammatory skin response score (time frame: 21 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 11 Aug 2015.