Healthy VolunteersPhase 1NCT02117752
Dermal Tolerability of Dapsone Gel in Healthy Volunteers
A Phase 1 study testing dapsone gel, sodium lauryl sulfate and Normal saline in people with Healthy Volunteers, run by Almirall, S.A. at 1 site in United States.
Trial summary
This study will determine the cumulative irritation potential and sensitization potential of dapsone gel and vehicle after repeat applications on the skin of healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- dapsone gel, sodium lauryl sulfate and Normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -Healthy adults.
Who cannot join
- Skin diseases, excessive hair, tattoos, pigmentation, scars or moles that could interfere with patch application
- Sensitivity to adhesive bandages or tape.
Trial locations and contacts
1 site in 1 country.
About this study
This study will determine the cumulative irritation potential and sensitization potential of dapsone gel and vehicle after repeat applications on the skin of healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- dapsone gel, dapsone gel vehicle, sodium lauryl sulfate, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dapsone gelDrug
Patches containing dapsone gel will be applied to the skin.
dapsone gel vehicleDrug
Patches containing dapsone gel vehicle will be applied to the skin.
sodium lauryl sulfateDrug
Patches containing sodium lauryl sulfate (Positive Control) will be applied to the skin.
Normal salineDrug
Patches containing normal saline (Negative Control) will be applied to the skin.
| Study group | Role | What they receive |
|---|---|---|
| Dapsone Gel Subset 1 | Experimental | Dapsone gel, dapsone gel vehicle and controls applied to the skin by separate occlusive patches every 24 hours for 21 days followed by a 10 to 17 day rest period then one application each of dapsone gel and dapsone gel vehicle by patch for 48-hours. Receives: Drug: dapsone gel; Drug: dapsone gel vehicle; Drug: sodium lauryl sulfate; Drug: Normal saline |
| Dapsone Gel Subset 2 | Experimental | Dapsone gel, dapsone gel vehicle and negative control applied to the skin by separate occlusive patches every 48 to 72 hours for 21 days followed by a 10 to 17 day rest period then one application each of dapsone gel and dapsone gel vehicle by patch for 48-hours. Receives: Drug: dapsone gel; Drug: dapsone gel vehicle; Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Cumulative Irritation Index During Induction Phase
Measured: 21 Days
Incidence of Sensitization Reactions During Challenge Phase
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2014
- Study completionJul 2014
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.
- More trials run by Almirall, S.A.The 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Allergan
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117752
- Sponsor's protocol ID
- 225678-009
- Status last verified
- Oct 2018
- First submitted
- 16 Apr 2014
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dermal Tolerability of Dapsone Gel in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02117752
- Acronym / sponsor ID
- 225678-009
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Collaborators
- Allergan
- Study start
- Apr 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 21 Apr 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 study will determine the cumulative irritation potential and sensitization potential of dapsone gel and vehicle after repeat applications on the skin of healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapsone Gel Subset 1 | Experimental | Drug: dapsone gel, Drug: dapsone gel vehicle, Drug: sodium lauryl sulfate, Drug: Normal salineDapsone gel, dapsone gel vehicle and controls applied to the skin by separate occlusive patches every 24 hours for 21 days followed by a 10 to 17 day rest period then one application each of dapsone gel and dapsone gel vehicle by patch for 48-hours. |
| Dapsone Gel Subset 2 | Experimental | Drug: dapsone gel, Drug: dapsone gel vehicle, Drug: Normal salineDapsone gel, dapsone gel vehicle and negative control applied to the skin by separate occlusive patches every 48 to 72 hours for 21 days followed by a 10 to 17 day rest period then one application each of dapsone gel and dapsone gel vehicle by patch for 48-hours. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Healthy adults.
Key exclusion criteria (2 listed)
- Skin diseases, excessive hair, tattoos, pigmentation, scars or moles that could interfere with patch application
- Sensitivity to adhesive bandages or tape.
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 |
|---|---|---|
| dapsone gelPatches containing dapsone gel will be applied to the skin. | Drug | Dapsone Gel Subset 1, Dapsone Gel Subset 2 |
| dapsone gel vehiclePatches containing dapsone gel vehicle will be applied to the skin. | Drug | Dapsone Gel Subset 1, Dapsone Gel Subset 2 |
| sodium lauryl sulfatePatches containing sodium lauryl sulfate (Positive Control) will be applied to the skin. | Drug | Dapsone Gel Subset 1 |
| Normal salinePatches containing normal saline (Negative Control) will be applied to the skin. | Drug | Dapsone Gel Subset 1, Dapsone Gel Subset 2 |
Primary outcome
Mean Cumulative Irritation Index During Induction Phase
Time frame: 21 Days
Incidence of Sensitization Reactions During Challenge Phase
Time frame: 6 Weeks
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 9 Oct 2018.
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Screening Protocol
Pain
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.
Medical Director study director
Allergan
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 dapsone gel, sodium lauryl sulfate and Normal saline in people with Healthy Volunteers, run by Almirall, S.A. 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 2 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 9 Oct 2018. 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. 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 Irritation Index During Induction Phase (time frame: 21 Days). 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 9 Oct 2018.