ScabiesPhase 2NCT02094716
A Dose Ranging Vehicle Controlled Study to Determine the Safety and Efficacy of Permethrin Foam, 5% and Permethrin Foam, 4% for the Treatment of Scabies
A Phase 2 study testing Permethrin Foam 4% and Permethrin Foam 5% in people with Scabies, run by Mylan Inc. at 9 sites in 4 countries.
Trial summary
To determine and compare the safety and efficacy of permethrin foam 4% and permethrin foam 5% with that of vehicle in subjects with scabies. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Scabies
- What is being tested?
- Permethrin Foam 4% and Permethrin Foam 5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 9 sitesin 4 countries
- Study dates
- Apr 2014to Dec 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of active scabies infection.
- Subject is in good general health with normal appearing skin in noninfested areas.
- Females must be post-menopausal, surgically sterile or use an effective method of birth control with a negative pregnancy test (10 years of age and older) at study start.
Who cannot join
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject has used any ectoparasiticide within the three weeks prior to study start.
- Subject has signs of systemic infection or is receiving systemic therapy for an infectious disease.
- Subject has severe cutaneous bacterial or fungal infections requiring therapy or heavily crusted lesions consistent with Norwegian scabies.
- Subject is currently enrolled in an investigational drug or device study or has used an investigational drug or device within 30 days prior to study start.
- Subject whose close personal contacts will not comply with standard of care for fomite management.
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
United States5 sites
Clinical Research Site
Fremont, California, 94538
Clinical Research Site
Hialeah, Florida, 33016
Clinical Research Site
Los Angeles, California, 90036
Clinical Research Site
New York, New York, 10018
Clinical Research Site
Philadelphia, Pennsylvania, 19103
Dominican Republic2 sites
Clinical Research Site
San Cristobal
Clinical Research Site
Santo Domingo
About this study
Official title: A Multicenter, Randomized, Double-Blind, Parallel Group Comparison Study of the Safety and Efficacy of Permethrin Foam, 5% Versus Permethrin Foam, 4% Versus Vehicle in Subjects With Sarcoptes Scabiei
To determine and compare the safety and efficacy of permethrin foam 4% and permethrin foam 5% with that of vehicle in subjects with scabies.
Read the detailed description
It is anticipated that a majority of subjects will require and receive a single treatment; however, those subjects not showing improvement at the follow-up visit 2 weeks after initial treatment will be treated a second time. Those subjects originally assigned to vehicle for the first treatment will receive a "re-treatment" with one of the active doses.
- Conditions
- Scabies
- Being tested
- Permethrin Foam 4%, Permethrin Foam 5%, Vehicle Foam
- Keywords
- Sarcoptes, Scabiei, Scabies, ectoparasite, parasite, infestation, Renaissance
- Medical subject headings
- Scabies, Parasitic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Permethrin Foam 4%Drug
Also called PF-045
Topical application, whole-body treatment
Permethrin Foam 5%Drug
Also called PF-055
Topical application, whole-body treatment
Vehicle FoamDrug
Also called Vehicle
Topical application, whole-body treatment
| Study group | Role | What they receive |
|---|---|---|
| Permethrin Foam 4%/ Permethrin Foam 4% | Experimental | First treatment with Permethrin Foam 4% with potential to re-treat with Permethrin Foam 4%, if necessary. Receives: Drug: Permethrin Foam 4% |
| Permethrin Foam 5%/ Permethrin Foam 5% | Experimental | First treatment with Permethrin Foam 5% with potential to re-treat with Permethrin Foam 5%, if necessary. Receives: Drug: Permethrin Foam 5% |
| Vehicle Foam / Permethrin Foam 4% | Placebo comparator | First treatment with Vehicle with potential to re-treat with Permethrin Foam 4%, if necessary. Receives: Drug: Permethrin Foam 4%; Drug: Vehicle Foam |
| Vehicle / Permethrin Foam 5% | Placebo comparator | First treatment with Vehicle with potential to re-treat with Permethrin Foam 5%, if necessary. Receives: Drug: Permethrin Foam 5%; Drug: Vehicle Foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Who Received a Single Treatment of the Assigned Test Article That Were Designated as "Treatment Success"
The primary efficacy variable is "treatment success". In protocol v2.0, "treatment success" was defined as an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear). In protocol v3.0, "treatment success" was defined as an "eradication of infestation": a) no burrows, b) a reduction in the Signs/Symptoms, and c) no evidence of a live mite on microscopy.
Measured: Day 28
Secondary outcomes (3)
Change in Disease-related Signs and Symptoms for Those Subjects Provided With Re-treatment at Day 14 Who Show Improvement in Their Investigator's Global Assessment (IGA) Score at Day 28
The change in the total score of signs and symptoms related to the condition in each treatment group at Days 14 and 28, as well as at Day 42 for those subjects provided with re-treatment at Day 14 who show improvement in their IGA score at Day 28.
Scale details: The overall average presence of the individual signs and symptoms of scabies was evaluated over the entire body. Erythema, papules, pustules, crusting, scaling, excoriations, and pruritus were assessed as follows for each sign and symptom: None=0, Trace=1, Mild=2, Moderate=3, Severe=4. From these assessments, the total score of the Signs and Symptoms (from 0 to 28, higher scores mean a worse outcome) was calculated as the sum of the individual signs and symptoms scores at Baseline and Days 2, 14, 28, and 42 (if applicable).The change from baseline in the total score can range from -28 as the best reduction possible (better outcome) to +28 as the worst increase possible (worse outcome) in signs and symptoms.
Measured: Baseline, Day 14, 28, and 42
Number of Re-treated Subjects Designated as "Treatment Success"
Each subject was designated as "re-treatment success" at Day 42 based upon the criteria in the protocol to which he/she was enrolled. In protocol v2.0, "treatment success" was defined as an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear). In protocol v3.0, "treatment success" was defined as an "eradication of infestation": a) no burrows, b) a reduction in the Signs/Symptoms, and c) no evidence of a live mite on microscopy.
Measured: Day 42
Number of Subjects Designated as "Treatment Success" Following One Treatment With an Active Dose
The proportion of subjects designated as "treatment success" following one treatment versus two treatments.
In protocol v2.0, "treatment success" was defined as an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear). In protocol v3.0, "treatment success" was defined as an "eradication of infestation": a) no burrows, b) a reduction in the Signs/Symptoms, and c) no evidence of a live mite on microscopy.
Subjects originally assigned to vehicle treatment and re-treated on Day 14 with an active dose will be included with the single treatment group for this analysis.
Subjects who did not improve at Day 14 were counted as failures at Day 28. Subjects who improved at Day 14 and received a second treatment in error were counted as failures at Day 28.
Measured: Day 28 and Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ScabiesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DPT Laboratories, Ltd., Vyne Therapeutics Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094716
- Sponsor's protocol ID
- 185-7851-201
- Status last verified
- Apr 2023
- First submitted
- 20 Mar 2014
- Last updated
- 26 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Parallel Group Comparison Study of the Safety and Efficacy of Permethrin Foam, 5% Versus Permethrin Foam, 4% Versus Vehicle in Subjects With Sarcoptes Scabiei
- ClinicalTrials.gov ID
- NCT02094716
- Acronym / sponsor ID
- 185-7851-201
- Conditions
- Scabies
- Keywords
- Sarcoptes, Scabiei, Scabies, ectoparasite, parasite, infestation, Renaissance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Mylan Inc.Industry (pharma, biotech, devices)
- Collaborators
- DPT Laboratories, Ltd., Vyne Therapeutics Inc.
- Study start
- Apr 2014 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 Mar 2014 (estimated)
- Results
- Posted 15 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine and compare the safety and efficacy of permethrin foam 4% and permethrin foam 5% with that of vehicle in subjects with scabies.
Detailed description
It is anticipated that a majority of subjects will require and receive a single treatment; however, those subjects not showing improvement at the follow-up visit 2 weeks after initial treatment will be treated a second time. Those subjects originally assigned to vehicle for the first treatment will receive a "re-treatment" with one of the active doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Permethrin Foam 4%/ Permethrin Foam 4% | Experimental | Drug: Permethrin Foam 4%First treatment with Permethrin Foam 4% with potential to re-treat with Permethrin Foam 4%, if necessary. |
| Permethrin Foam 5%/ Permethrin Foam 5% | Experimental | Drug: Permethrin Foam 5%First treatment with Permethrin Foam 5% with potential to re-treat with Permethrin Foam 5%, if necessary. |
| Vehicle Foam / Permethrin Foam 4% | Placebo comparator | Drug: Permethrin Foam 4%, Drug: Vehicle FoamFirst treatment with Vehicle with potential to re-treat with Permethrin Foam 4%, if necessary. |
| Vehicle / Permethrin Foam 5% | Placebo comparator | Drug: Permethrin Foam 5%, Drug: Vehicle FoamFirst treatment with Vehicle with potential to re-treat with Permethrin Foam 5%, if necessary. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of active scabies infection.
- Subject is in good general health with normal appearing skin in noninfested areas.
- Females must be post-menopausal, surgically sterile or use an effective method of birth control with a negative pregnancy test (10 years of age and older) at study start.
Key exclusion criteria (6 listed)
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject has used any ectoparasiticide within the three weeks prior to study start.
- Subject has signs of systemic infection or is receiving systemic therapy for an infectious disease.
- Subject has severe cutaneous bacterial or fungal infections requiring therapy or heavily crusted lesions consistent with Norwegian scabies.
- Subject is currently enrolled in an investigational drug or device study or has used an investigational drug or device within 30 days prior to study start.
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 |
|---|---|---|
| Permethrin Foam 4%Also: PF-045Topical application, whole-body treatment | Drug | Permethrin Foam 4%/ Permethrin Foam 4%, Vehicle Foam / Permethrin Foam 4% |
| Permethrin Foam 5%Also: PF-055Topical application, whole-body treatment | Drug | Permethrin Foam 5%/ Permethrin Foam 5%, Vehicle / Permethrin Foam 5% |
| Vehicle FoamAlso: VehicleTopical application, whole-body treatment | Drug | Vehicle / Permethrin Foam 5%, Vehicle Foam / Permethrin Foam 4% |
Primary outcome
Number of Subjects Who Received a Single Treatment of the Assigned Test Article That Were Designated as "Treatment Success"
Time frame: Day 28
The primary efficacy variable is "treatment success". In protocol v2.0, "treatment success" was defined as an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear). In protocol v3.0, "treatment success" was defined as an "eradication of infestation": a) no burrows, b) a reduction in the Signs/Symptoms, and c) no evidence of a live mite on microscopy.
3 secondary outcomes
Change in Disease-related Signs and Symptoms for Those Subjects Provided With Re-treatment at Day 14 Who Show Improvement in Their Investigator's Global Assessment (IGA) Score at Day 28
Time frame: Baseline, Day 14, 28, and 42
Number of Re-treated Subjects Designated as "Treatment Success"
Time frame: Day 42
Number of Subjects Designated as "Treatment Success" Following One Treatment With an Active Dose
Time frame: Day 28 and Day 42
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Scabies
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.
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Permethrin Foam 4% and Permethrin Foam 5% in people with Scabies, run by Mylan Inc. at 9 sites in 4 countries.
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 3 inclusion and 6 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 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Dominican Republic, Honduras, Puerto Rico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects Who Received a Single Treatment of the Assigned Test Article That Were Designated as "Treatment Success" (time frame: Day 28). 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 26 Apr 2023.