Skin IrritationPhase 1NCT03397862
A Skin Irritation Assessment of Once-Weekly Corplex™ Donepezil Transdermal Delivery System
A Phase 1 study testing Donepezil TDS in people with Skin Irritation and Sensitization, run by Corium, Inc. at 2 sites in United States.
Trial summary
A study to assess the skin irritation and sensitization potential of Corplex™ Donepezil Transdermal Delivery System (TDS) Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Irritation, Sensitization
- What is being tested?
- Donepezil TDS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Nov 2017to 2 Apr 2018
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, adult, male or female
- Body mass index ≥ 18.0 and ≤ 35.0 kg/m2
- Medically healthy, as deemed by the Investigator
- Have a skin type with Fitzpatrick scale score of I, II, or III
Who cannot join
- History or presence of alcoholism or drug abuse
- History or presence of hypersensitivity or idiosyncratic reaction to the study product or related compounds
- Positive urine drug or alcohol results
- Female subjects with a positive pregnancy test or who are lactating
- Any of the following drugs, but not limited to, for 30 days prior to the first dose of study product treatment on Day 1 and throughout the study:
- Inducers of cytochrome enzymes and/or P-glycoprotein
Show all 13Show fewer
- Anti-inflammatory drugs or cyclooxygenase 2 analgesics
- Beta-blockers
- Cholinergics and anticholinergics
- Muscle relaxants, anti-Parkinsonian, or neuroleptic medications
- History or presence of significant skin damage deemed by the investigator to potentially interfere
- Any medical or surgical procedure or trauma
- Participation in another clinical study within 30 days or 5 times the half-life of the investigational product (whichever is longer) prior to the first study product treatment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Celerion Inc.
Lincoln, Nebraska, 68502
Celerion Inc.
Phoenix, Arizona, 85283
About this study
Official title: A Randomized Double-Blind Study to Assess the Skin Irritation and Sensitization Potential of Once-Weekly Corplex™ Donepezil Transdermal Delivery System
A study to assess the skin irritation and sensitization potential of Corplex™ Donepezil Transdermal Delivery System (TDS)
Read the detailed description
This study is a multiple center, randomized, double-blind, vehicle-controlled, and multiple-dose study to assess skin irritation and skin sensitization in healthy subjects.
Subjects will be randomized prior to the first TDS application. The total duration of the study from Screening to Follow-up is approximately 95 days for subjects participating in the Induction Phase and the Challenge Phase of the study and potentially up to 156 days for subjects requiring to complete Re-Challenge Phase.
Skin irritation will be monitored by visual scoring scales. TDS adhesion will be assessed during TDS wear period. Safety will be monitored throughout the study by clinical and laboratory evaluations.
- Conditions
- Skin Irritation, Sensitization
- Being tested
- Donepezil TDS, Vehicle TDS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donepezil TDSDrug
Donepezil patch
Vehicle TDSDrug
Placebo patch
| Study group | Role | What they receive |
|---|---|---|
| Corplex Donepezil TDS 5 mg/day | Experimental | Subjects will receive Corplex Donepezil TDS 5 mg/day during Induction, Challenge, and Re-Challenge phase. Receives: Drug: Donepezil TDS |
| Vehicle TDS | Placebo comparator | Subjects will receive Vehicle TDS during Induction, Challenge, and Re-Challenge phase. Receives: Drug: Vehicle TDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Cumulative Skin Irritation Score of Donepezil Corplex TDS (Induction Phase)
Mean Cumulative skin irritation score is determined by averaging the combined Dermal Response score (8-point categorical scale using numeric values) and the Other Effects score (6-point categorical scale using alphabet letters equivalent to numeric values) during the induction phase of the study.
Measured: Induction (21 days)
Number of Subjects with Skin sensitization potential of Corplex TDS (Challenge Phase)
Subject's sensitization potential will be assessed using the combined Dermal Response score (8-point categorical scale using numeric values) and the Other Effects score (6-point categorical scale using alphabet letters equivalent to numeric values) . The last of 48 hr or 72 hr score collected after TDS removal during the Challenge Phase will be assessed. Provided the combined score is 2 or greater, it will then be compared to the skin irritation scores collected during the induction phase. If the last Challenge Phase score is 2 or greater and generally exceeds the skin irritation scores collected during the induction phase, the subject will return for the Re-Challenge phase.
Measured: Challenge: Up to 5 days including 2-day TDS application and a 3-day visual scoring of the TDS application site following TDS removal
Number of Subjects with Skin sensitization potential of Corplex TDS (Re-Challenge Phase)
Subject's sensitization potential will be assessed using the combined Dermal Response score (8-point categorical scale using numeric values) and the Other Effects score (6-point categorical scale using alphabet letters equivalent to numeric values). The last of 48 hr or 72 hr score collected after TDS removal during the Re-Challenge phase will be assessed. The subject will be considered for potential sensitization if they meet the same criteria in both Challenge phase and Re-Challenge phase (i.e. a combined score of 2 or greater at the last assessment at 48 hr or 72 hr post patch removal and the score are generally higher compared to induction phase scores.
Measured: Re-Challenge: Up to 5 days including 2-day TDS application and a 3-day visual scoring of the TDS application site following TDS removal
Secondary outcomes (1)
Mean Cumulative Skin Irritation Score of Donepezil Corplex TDS compared to Vehicle TDS (Induction Phase)
Mean cumulative skin irritation will be determined and compared between Corplex Donepezil TDS and Vehicle TDS. Mean Cumulative skin irritation score is determined by averaging the combined Dermal Response score (8-point categorical scale using numeric values) and the Other Effects score (6-point categorical scale using alphabet letters equivalent to numeric values) during the induction phase of the study.
Measured: Induction (21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start14 Nov 2017
- Primary completion8 Mar 2018
- Study completion2 Apr 2018
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.
- 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
- Sequential
- Model description
- Induction Phase will consist of application of the once-weekly TDS for 3 consecutive weeks to the same skin site, followed by a rest period of 2 weeks. The TDS application site will be visually scored for skin irritation approximately 30 minutes following each patch removal and prior to the next patch application. The Challenge Phase will consist of 2 days of TDS application followed by 3 days of visual scoring of TDS application site following TDS removal. Subjects meeting the guidance criteria for Re-Challenge phase will continue with a rest period of 4-8 weeks, followed by 2-day TDS application and a 3-day visual scoring of the TDS application site following TDS removal.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corium, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Danielle Armas, MD, CPI, Principal investigator, CelerionLaura Sterling, MD, MPH, Principal investigator, CelerionVaeling Miller, Study director, Corium International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397862
- Sponsor's protocol ID
- P-16011
- Status last verified
- Sep 2018
- First submitted
- 3 Nov 2017
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No plans
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Study to Assess the Skin Irritation and Sensitization Potential of Once-Weekly Corplex™ Donepezil Transdermal Delivery System
- ClinicalTrials.gov ID
- NCT03397862
- Acronym / sponsor ID
- P-16011
- Conditions
- Skin Irritation, Sensitization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Corium, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 8 Mar 2018 (actual)
- Study completion
- 2 Apr 2018 (actual)
- First posted
- 12 Jan 2018 (actual)
- 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.
A study to assess the skin irritation and sensitization potential of Corplex™ Donepezil Transdermal Delivery System (TDS)
Detailed description
This study is a multiple center, randomized, double-blind, vehicle-controlled, and multiple-dose study to assess skin irritation and skin sensitization in healthy subjects.
Subjects will be randomized prior to the first TDS application. The total duration of the study from Screening to Follow-up is approximately 95 days for subjects participating in the Induction Phase and the Challenge Phase of the study and potentially up to 156 days for subjects requiring to complete Re-Challenge Phase.
Skin irritation will be monitored by visual scoring scales. TDS adhesion will be assessed during TDS wear period. Safety will be monitored throughout the study by clinical and laboratory evaluations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Induction Phase will consist of application of the once-weekly TDS for 3 consecutive weeks to the same skin site, followed by a rest period of 2 weeks. The TDS application site will be visually scored for skin irritation approximately 30 minutes following each patch removal and prior to the next patch application. The Challenge Phase will consist of 2 days of TDS application followed by 3 days of visual scoring of TDS application site following TDS removal. Subjects meeting the guidance criteria for Re-Challenge phase will continue with a rest period of 4-8 weeks, followed by 2-day TDS application and a 3-day visual scoring of the TDS application site following TDS removal.
| Arm | Type | Receives |
|---|---|---|
| Corplex Donepezil TDS 5 mg/day | Experimental | Drug: Donepezil TDSSubjects will receive Corplex Donepezil TDS 5 mg/day during Induction, Challenge, and Re-Challenge phase. |
| Vehicle TDS | Placebo comparator | Drug: Vehicle TDSSubjects will receive Vehicle TDS during Induction, Challenge, and Re-Challenge phase. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy, adult, male or female
- Body mass index ≥ 18.0 and ≤ 35.0 kg/m2
- Medically healthy, as deemed by the Investigator
- Have a skin type with Fitzpatrick scale score of I, II, or III
Key exclusion criteria (13 listed)
- History or presence of alcoholism or drug abuse
- History or presence of hypersensitivity or idiosyncratic reaction to the study product or related compounds
- Positive urine drug or alcohol results
- Female subjects with a positive pregnancy test or who are lactating
- Any of the following drugs, but not limited to, for 30 days prior to the first dose of study product treatment on Day 1 and throughout the study:
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 |
|---|---|---|
| Donepezil TDSDonepezil patch | Drug | Corplex Donepezil TDS 5 mg/day |
| Vehicle TDSPlacebo patch | Drug | Vehicle TDS |
Primary outcome
Mean Cumulative Skin Irritation Score of Donepezil Corplex TDS (Induction Phase)
Time frame: Induction (21 days)
Mean Cumulative skin irritation score is determined by averaging the combined Dermal Response score (8-point categorical scale using numeric values) and the Other Effects score (6-point categorical scale using alphabet letters equivalent to numeric values) during the induction phase of the study.
Number of Subjects with Skin sensitization potential of Corplex TDS (Challenge Phase)
Time frame: Challenge: Up to 5 days including 2-day TDS application and a 3-day visual scoring of the TDS application site following TDS removal
Subject's sensitization potential will be assessed using the combined Dermal Response score (8-point categorical scale using numeric values) and the Other Effects score (6-point categorical scale using alphabet letters equivalent to numeric values) . The last of 48 hr or 72 hr score collected after TDS removal during the Challenge Phase will be assessed. Provided the combined score is 2 or greater, it will then be compared to the skin irritation scores collected during the induction phase. If the last Challenge Phase score is 2 or greater and generally exceeds the skin irritation scores collected during the induction phase, the subject will return for the Re-Challenge phase.
Number of Subjects with Skin sensitization potential of Corplex TDS (Re-Challenge Phase)
Time frame: Re-Challenge: Up to 5 days including 2-day TDS application and a 3-day visual scoring of the TDS application site following TDS removal
Subject's sensitization potential will be assessed using the combined Dermal Response score (8-point categorical scale using numeric values) and the Other Effects score (6-point categorical scale using alphabet letters equivalent to numeric values). The last of 48 hr or 72 hr score collected after TDS removal during the Re-Challenge phase will be assessed. The subject will be considered for potential sensitization if they meet the same criteria in both Challenge phase and Re-Challenge phase (i.e. a combined score of 2 or greater at the last assessment at 48 hr or 72 hr post patch removal and the score are generally higher compared to induction phase scores.
1 secondary outcome
Mean Cumulative Skin Irritation Score of Donepezil Corplex TDS compared to Vehicle TDS (Induction Phase)
Time frame: Induction (21 days)
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 14 Sep 2018.
- Individual participant dataSharing planned: No. No plans
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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.
Danielle Armas, MD, CPI principal investigator
Celerion
Laura Sterling, MD, MPH principal investigator
Celerion
Vaeling Miller study director
Corium International
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Donepezil TDS in people with Skin Irritation and Sensitization, run by Corium, Inc. at 2 sites 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 4 inclusion and 13 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 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Mean Cumulative Skin Irritation Score of Donepezil Corplex TDS (Induction Phase) (time frame: Induction (21 days)). The study lists 3 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 14 Sep 2018.