ScabiesPhase 3NCT02978508
Bio-equivalence Study Comparing Permethrin Cream, 5% With Elimite in Patients With Active Scabies.
A Phase 3 study testing Permethrin Cream, 5% and Elimite in people with Scabies, run by Mayne Pharma International Pty Ltd at 3 sites in United States.
Trial summary
This is a multi-center, double-blind, randomized, two arm parallel design study. This study is comprised of two phases: screening and treatment. The screening period will be up to 5 days, followed by the treatment phase of 28±4 days. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Scabies
- What is being tested?
- Permethrin Cream, 5% and Elimite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2016to May 2017
- Phase
- Phase 3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or non-pregnant, non-lactating female subject at least 12 years of age or older.
- Subject must have a positive identification for mites, eggs, or mite fecal matter by microscopic examination of a skin scraping.
- Subjects must have at least two of the three following: a) excoriations and inflammatory papules with a typical distribution pattern and localization (webbed spaces of the fingers, flexor surfaces of the wrists, elbows, axillae, belt line, feet, skin surface of external genitalia, or areolae); b) presence of burrows; c) family or contacts with moderate to severe itching which increases during the night.
- Subjects must be willing to make every effort to immediately disinfect clothes, towels, and linens and all potentially infected household items upon diagnosis of infestation to prevent re-infestation.
- All household members with prolonged physical contact with the subject must be willing to attend Baseline visit and receive treatment with standard of care if deemed necessary by the Investigator in order to prevent re-infestation of the subject enrolled.
- Subject or representative must read and sign an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved Informed Consent Form (ICF); for minor subjects (18 years or younger in most states) the parent or legal guardian should sign the ICF and the child will be required to sign the Assent Form that will written in such a way as to be understandable to a child.
- Subject must be able to apply study product to self. If the subject is a child, then parent/guardian will apply study product to him/her.
Who cannot join
- Females who are pregnant as shown in a urine pregnancy test at the Baseline visit, prior to randomization, or lactating, or of childbearing potential (for purpose of this study a female of childbearing potential is considered to be not surgically sterile or postmenopausal for at least 1 year) who are not using or do not agree to use an acceptable form of contraception (oral /implant /injectable /transdermal contraceptives, intrauterine device (IUD), condom, diaphragm, or abstinence) during the study, or who intends to become pregnant during the study; contraceptive method must also be consistent throughout the study.
- Treatment for scabies <4 weeks prior to enrollment, including permethrin, benzyl alcohol, lindane, crotamiton, malathion, and ivermectin.
- Use of prohibited medications:
- Topical or oral scabicidal/antiparasitic treatment including: permethrin, benzyl alcohol, benzyl benzoate, lindane, crotamiton, malathion, ivermectin, precipitated sulfur, albendazole, keratolytic cream, tea tree oil, or oil of the leaves of Lippia multiflora Moldenke within 28 days of visit 2.
- Systemic corticosteroids (including inhaled steroids) taken within 14 days of visit 2.
- Topical corticosteroids including hydrocortisone taken within 24 hours of visit 2.
Show all 20Show fewer
- Topical antipruritics, including antihistamines within 24 hours of any study visits.
- Oral antihistamine including diphenhydramine (Benadryl) taken within 24 hours of any study visits.
- Topical antibiotics including mupirocin taken within 24 hours of any study visits.
- Patients with immunosuppressive disorders requiring therapy, severe systemic disease, history of HIV infection and/or seizures.
- Patients with crusted/Norwegian scabies.
- Presence of underlying skin disease that would obscure evaluation of the papules and burrows associated with scabies infection as determined by the Investigator.
- Presence of severe cutaneous bacterial or fungal infections requiring therapy (including systemic and topical antibiotics) as determined by the Investigator.
- Sensitivity or allergy to Permethrin Cream or any of its components, synthetic pyrethroids, pyrethrin, chrysanthemums or ragweed.
- A recent (less than 1 year) history of alcoholism, drug abuse, or other problems which would likely make the subject unreliable for the study.
- Participation in another investigational study or using any investigational product within the 30 days prior to the Baseline visit.
- Participation of family member, or another member of the household (including regular bedmates) in the current study.
- Total number of bedmates and family members with prolonged physical contact is greater than 6 (including study subject).
- Any employees of the clinic, investigators, or family members of the study staff.
- Patients who in the opinion of the Investigator would be non-compliant with the requirements of the study protocol.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
LCC Medical Research Institute
Miami, Florida, 33126
Southcoast Research Center
Miami, Florida, 33136
Mid Columbia Research
Richland, Washington, 99352
About this study
Official title: A Multi-center, Double-blind, Randomized, Parallel-group Study Comparing Permethrin Cream, 5% With Elimite™ in Patients With Active Scabies.
This is a multi-center, double-blind, randomized, two arm parallel design study. This study is comprised of two phases: screening and treatment. The screening period will be up to 5 days, followed by the treatment phase of 28±4 days. During the treatment phase subjects will be randomized to receive either test or reference treatments in a double-blind manner in an outpatient setting. Randomization of subjects will be in a 1:1 ratio for the test and reference drug arms and will be stratified by site.
Screening will begin at visit 1, during which eligibility will be determined and prohibited treatments will be discontinued. Randomization will occur following the confirmation of the eligibility criteria at visit 2 (baseline, Day 1) i.e. initiation of treatment phase. The treatment phase will be 28±4 days in duration wherein subject will receive treatment with investigational product (either test or reference) on Day 1 or Baseline (visit 2). Safety and tolerability assessments will be performed on Day 7 (visit 3). Efficacy, safety and tolerability will be assessed on Day 14 (visit 4) followed by the End of study visit on Day 28 (visit 5). If positive identification of scabies is confirmed at Day 14 (visit 4), the subject will be retreated with the second application of the investigational product.
Read the detailed description
Systemic absorption of permethrin cream is limited to 0.5% during the first 48 hours following dermal application. In these settings, a conventional pharmacokinetic human study to demonstrate that Mayne Permethrin cream (5% w/w) is bioequivalent to the Reference Listed Drug [RLD] Elimite™ is not appropriate.
This is a clinical endpoint bioequivalence (BE) study for a Permethrin Cream, 5% formulation for the treatment of active scabies in comparison to Elimite™ Permethrin cream (5% w/w).
- Test Product: Permethrin Cream, 5%
- Reference Product: Elimite™ marketed by Prestium Pharma, Inc. ("Prestium"), the branded subsidiary of Renaissance Pharma.
The infested person, as well as household members are treated at the same time to prevent re-infestation. In consideration of this recommendation, the household members of the enrolled subject will be examined and treated at the same time as the enrolled subject with an FDA-approved generic Permethrin Cream, 5%.
- Conditions
- Scabies
- Being tested
- Permethrin Cream, 5%, Elimite
- Medical subject headings
- Scabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Permethrin Cream, 5%Drug
Subjects on Test product will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.
ElimiteDrug
Also called Permethrin Cream, 5%
Subjects on RLD will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.
| Study group | Role | What they receive |
|---|---|---|
| Permethrin Cream, 5% | Experimental | Permethrin Cream 5%, topical cream, 60g, maximum of two doses over 28 day treatment duration. Receives: Drug: Permethrin Cream, 5% |
| Elimite | Active comparator | Elimite™ 60g, topical, marketed by Prestium Pharma, Inc. ("Prestium"), the branded subsidiary of Renaissance Pharma, maximum of two doses over 28 day treatment duration. Receives: Drug: Elimite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients That Are Identified as Cured.
To demonstrate bioequivalence between Permethrin Cream, 5% (Test) and Elimite™ (Reference) in patients with active scabies.
Measured: Day 28
Secondary outcomes (1)
Proportion of Patients That Are Identified as Cured.
To demonstrate bioequivalence between Permethrin Cream, 5% (Test) and Elimite™ (Reference) in patients with active scabies.
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionMay 2017
- Study completionMay 2017
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayne Pharma International Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- bioRASI, LLC
- Responsible party
- Sponsor
- Investigators
- Phoevos Hughes, JD, Study director, bioRASI, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978508
- Sponsor's protocol ID
- MAP-8184
- Status last verified
- Aug 2020
- First submitted
- 17 Nov 2016
- Last updated
- 2 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blind, Randomized, Parallel-group Study Comparing Permethrin Cream, 5% With Elimite™ in Patients With Active Scabies.
- ClinicalTrials.gov ID
- NCT02978508
- Acronym / sponsor ID
- MAP-8184
- Conditions
- Scabies
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Mayne Pharma International Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- bioRASI, LLC
- Study start
- Nov 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 1 Dec 2016 (estimated)
- Results
- Posted 2 Sep 2020
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 multi-center, double-blind, randomized, two arm parallel design study. This study is comprised of two phases: screening and treatment. The screening period will be up to 5 days, followed by the treatment phase of 28±4 days. During the treatment phase subjects will be randomized to receive either test or reference treatments in a double-blind manner in an outpatient setting. Randomization of subjects will be in a 1:1 ratio for the test and reference drug arms and will be stratified by site.
Screening will begin at visit 1, during which eligibility will be determined and prohibited treatments will be discontinued. Randomization will occur following the confirmation of the eligibility criteria at visit 2 (baseline, Day 1) i.e. initiation of treatment phase. The treatment phase will be 28±4 days in duration wherein subject will receive treatment with investigational product (either test or reference) on Day 1 or Baseline (visit 2). Safety and tolerability assessments will be performed on Day 7 (visit 3). Efficacy, safety and tolerability will be assessed on Day 14 (visit 4) followed by the End of study visit on Day 28 (visit 5). If positive identification of scabies is confirmed at Day 14 (visit 4), the subject will be retreated with the second application of the investigational product.
Detailed description
Systemic absorption of permethrin cream is limited to 0.5% during the first 48 hours following dermal application. In these settings, a conventional pharmacokinetic human study to demonstrate that Mayne Permethrin cream (5% w/w) is bioequivalent to the Reference Listed Drug [RLD] Elimite™ is not appropriate.
This is a clinical endpoint bioequivalence (BE) study for a Permethrin Cream, 5% formulation for the treatment of active scabies in comparison to Elimite™ Permethrin cream (5% w/w).
- Test Product: Permethrin Cream, 5%
- Reference Product: Elimite™ marketed by Prestium Pharma, Inc. ("Prestium"), the branded subsidiary of Renaissance Pharma.
The infested person, as well as household members are treated at the same time to prevent re-infestation. In consideration of this recommendation, the household members of the enrolled subject will be examined and treated at the same time as the enrolled subject with an FDA-approved generic Permethrin Cream, 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Permethrin Cream, 5% | Experimental | Drug: Permethrin Cream, 5%Permethrin Cream 5%, topical cream, 60g, maximum of two doses over 28 day treatment duration. |
| Elimite | Active comparator | Drug: ElimiteElimite™ 60g, topical, marketed by Prestium Pharma, Inc. ("Prestium"), the branded subsidiary of Renaissance Pharma, maximum of two doses over 28 day treatment duration. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Male or non-pregnant, non-lactating female subject at least 12 years of age or older.
- Subject must have a positive identification for mites, eggs, or mite fecal matter by microscopic examination of a skin scraping.
- Subjects must have at least two of the three following: a) excoriations and inflammatory papules with a typical distribution pattern and localization (webbed spaces of the fingers, flexor surfaces of the wrists, elbows, axillae, belt line, feet, skin surface of external genitalia, or areolae); b) presence of burrows; c) family or contacts with moderate to severe itching which increases during the night.
- Subjects must be willing to make every effort to immediately disinfect clothes, towels, and linens and all potentially infected household items upon diagnosis of infestation to prevent re-infestation.
- All household members with prolonged physical contact with the subject must be willing to attend Baseline visit and receive treatment with standard of care if deemed necessary by the Investigator in order to prevent re-infestation of the subject enrolled.
Key exclusion criteria (20 listed)
- Females who are pregnant as shown in a urine pregnancy test at the Baseline visit, prior to randomization, or lactating, or of childbearing potential (for purpose of this study a female of childbearing potential is considered to be not surgically sterile or postmenopausal for at least 1 year) who are not using or do not agree to use an acceptable form of contraception (oral /implant /injectable /transdermal contraceptives, intrauterine device (IUD), condom, diaphragm, or abstinence) during the study, or who intends to become pregnant during the study; contraceptive method must also be consistent throughout the study.
- Treatment for scabies <4 weeks prior to enrollment, including permethrin, benzyl alcohol, lindane, crotamiton, malathion, and ivermectin.
- Use of prohibited medications:
- Patients with immunosuppressive disorders requiring therapy, severe systemic disease, history of HIV infection and/or seizures.
- Patients with crusted/Norwegian scabies.
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 Cream, 5%Subjects on Test product will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary. | Drug | Permethrin Cream, 5% |
| ElimiteAlso: Permethrin Cream, 5%Subjects on RLD will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary. | Drug | Elimite |
Primary outcome
Proportion of Patients That Are Identified as Cured.
Time frame: Day 28
To demonstrate bioequivalence between Permethrin Cream, 5% (Test) and Elimite™ (Reference) in patients with active scabies.
1 secondary outcome
Proportion of Patients That Are Identified as Cured.
Time frame: Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Phoevos Hughes, JD study director
bioRASI, LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Permethrin Cream, 5% and Elimite in people with Scabies, run by Mayne Pharma International Pty Ltd at 3 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 7 inclusion and 20 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 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 2 Sep 2020). 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?
Proportion of Patients That Are Identified as Cured. (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 2 Sep 2020.