ScabiesPhase 3NCT03178942
Multiple-Site Study to Evaluate the Therapeutic Equivalence of Permethrin Cream, 5% in the Treatment of Scabies
A Phase 3 study testing Permethrin Cream, 5% and Elimite™ Cream (permethrin) 5% in people with Scabies, run by Encube Ethicals Pvt. Ltd. at 15 sites in 3 countries.
Trial summary
Study to Evaluate the Therapeutic Equivalence of Permethrin Cream 5%in the Treatment of Scabies. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Scabies
- What is being tested?
- Permethrin Cream, 5% and Elimite™ Cream (permethrin) 5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 1 Jun 2017to 11 Nov 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 2 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, 2 years of age or older.
- If female and of childbearing potential, prepared to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., double barrier methods, intrauterine device (IUD), oral, transdermal or injected hormonal contraceptives). Female patients using hormonal contraceptives should have been on the same product/dosing regimen for at least 28 days before baseline and should not change this regimen during the study.
- Signed informed consent that meets all criteria of current FDA and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) regulations. For patients who are considered minors in the state the study is being conducted (< 18 years in most states) the parent or legal guardian should sign the consent form and the child will be required to sign a patient "assent" form, as appropriate. Patients 11-17 years of age will read and sign an Independent Review Board (IRB)-approved assent form and patients 6-10 years of age will provide verbal assent. Patients 2-5 years of age will be exempt from providing assent based on the child's comprehension and cognitive skills.
- Clinical diagnosis of active scabies by presence of a burrow and/or typical scabietic lesions at the classic sites of infestation.
- Parasitological confirmation of clinical diagnosis with demonstration under light microscope of mites and/or their products (larvae, eggs or fecal material).
- Symptom score of 2 or 3 on a 4-point rating scale of 0-3 for nocturnal itching/pruritus.
- Ability to apply or have study product applied as directed. If patient is a child, then parent/guardian will apply study product to him/her.
Who cannot join
- Patients who are pregnant, lactating, or planning to become pregnant during the study.
- Any systemic or dermatologic disorder that, in the opinion of the Investigator, will interfere with the study results or increase the risk of adverse events (AEs).
- Known hypersensitivity to permethrin cream or any of its components.
- Use of any systemic or topical acaricide or ectoparasiticide within one month before Screening.
- Patient has signs of a systemic infection or is receiving systemic therapy for an infectious disease.
- Patients with severe cutaneous bacterial or fungal infections requiring therapy (including systemic and topical antibiotics) or coexisting dermatological disorder that could interfere with the diagnosis and subsequent monitoring of scabies) or heavily crusted with lesions consistent with Norwegian scabies.
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- Patients with an underlying immunodeficient state (including prolonged treatment with corticosteroids), immunosuppressive disorders requiring therapy, severe systemic disease and history of HIV infection.
- Any condition, medical, psychological, or social, that, in the Investigator's opinion, would interfere with participation in the study.
- Family members of employees of the clinic or Investigator.
- Patients who, in the opinion of the Investigator, would be non-compliant with the requirements of the study protocol.
- Patients whose close personal contacts will not or are not willing to comply with standard of care for Scabies management.
- Receipt of any drug as part of a research study within 30 days before Screening.
- History of seizures.
- Use of systemic corticosteroids within two weeks before Screening.
- Use of topical corticosteroids within one week before Screening.
- Previous participation in this study.
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
United States10 sites
St. Josephs Clinical Research
Anaheim, California, 92804
DermDox Cetners for Dermatology
Hazleton, Pennsylvania, 18201
Integrity Clinical Research Center, Inc.
Hialeah, Florida, 33015
West Houston Clinical Research Services
Houston, Texas, 77055
The Chappel Group Research
Kissimmee, Florida, 34744
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212
Long Beach Clinical Trials
Long Beach, California, 90806
Havana Research Institute
Pasadena, California, 91105
Sun Research Instiute
San Antonio, Texas, 78215
Lenus Research & Medical Group, LLC
Sweetwater, Florida, 33172
El Salvador3 sites
Clinica Dermatologica/APF Research International
San Salvador, O1101
Clinica Dermatologica Y Cirugia de Piel/APF Research International
San Salvador, O1501
Clinica de la Doctora Laura Vargas
San Salvador
Puerto Rico2 sites
APF Research International
Aguas Buenas, OO703
APF Research International
Loiza, OO772
About this study
Official title: A Randomized, Double-Blind, Parallel-Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Permethrin Cream, 5% (Encube Ethicals) Compared to Elimite™ Cream (Permethrin) 5% (Prestium Pharma, Inc.) in the Treatment of Scabies
Study to Evaluate the Therapeutic Equivalence of Permethrin Cream 5%in the Treatment of Scabies.
Read the detailed description
A Randomized, Double-Blind, Parallel-Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Permethrin Cream 5% (Encube Ethicals) Compared to Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.) in the Treatment of Scabies.
The objectives of this study are to:
- Evaluate the therapeutic equivalence of the Test formulation, Permethrin Cream, 5% (Encube Ethicals) to the marketed product, Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.) in patients with scabies.
- Compare the safety of Test and Reference treatments in patients with scabies.
- Conditions
- Scabies
- Being tested
- Permethrin Cream, 5%, Elimite™ Cream (permethrin) 5%
- 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
Permethrin Cream 5%
Elimite™ Cream (permethrin) 5%Drug
Also called Elimite™ Cream
Permethrin Cream 5%
| Study group | Role | What they receive |
|---|---|---|
| Reference: Elimite™ Cream | Active comparator | Reference: Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.) Receives: Drug: Elimite™ Cream (permethrin) 5% |
| Test: Permethrin Cream, 5% | Experimental | Test: Permethrin Cream, 5% (Encube Ethicals) Receives: Drug: Permethrin Cream, 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients in Each Treatment Group With Therapeutic Cure (Parasitological Cure Plus Clinical Cure) of Scabies
Parasitological cure is defined as failure to demonstrate microscopically the presence of scabies infestation (i.e., no living mites, no viable mite eggs, and no mite fecal matter present).
Clinical cure is defined as visual evidence of absence of new lesions and healing of original lesions, regardless the presence of post-scabietic nodules (i.e., post-scabietic nodules need not be considered as new lesions or persistence of old lesions).
Measured: Day 28 ± 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start1 Jun 2017
- Primary completion11 Nov 2017
- Study completion11 Nov 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
- Model description
- Patients will be assigned to the test or reference permethrin to treat scabies.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Encube Ethicals Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novum Pharmaceutical Research Services
- Responsible party
- Sponsor
- Investigators
- Pratik Kamani, Study director, Encube Ethicals Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178942
- Sponsor's protocol ID
- 71675502
- Status last verified
- Feb 2019
- First submitted
- 31 May 2017
- Last updated
- 26 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Permethrin Cream, 5% (Encube Ethicals) Compared to Elimite™ Cream (Permethrin) 5% (Prestium Pharma, Inc.) in the Treatment of Scabies
- ClinicalTrials.gov ID
- NCT03178942
- Acronym / sponsor ID
- 71675502
- Conditions
- Scabies
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Encube Ethicals Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Novum Pharmaceutical Research Services
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 11 Nov 2017 (actual)
- Study completion
- 11 Nov 2017 (actual)
- First posted
- 7 Jun 2017 (actual)
- Results
- Posted 14 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to Evaluate the Therapeutic Equivalence of Permethrin Cream 5%in the Treatment of Scabies.
Detailed description
A Randomized, Double-Blind, Parallel-Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Permethrin Cream 5% (Encube Ethicals) Compared to Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.) in the Treatment of Scabies.
The objectives of this study are to:
- Evaluate the therapeutic equivalence of the Test formulation, Permethrin Cream, 5% (Encube Ethicals) to the marketed product, Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.) in patients with scabies.
- Compare the safety of Test and Reference treatments in patients with scabies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be assigned to the test or reference permethrin to treat scabies.
| Arm | Type | Receives |
|---|---|---|
| Reference: Elimite™ Cream | Active comparator | Drug: Elimite™ Cream (permethrin) 5%Reference: Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.) |
| Test: Permethrin Cream, 5% | Experimental | Drug: Permethrin Cream, 5%Test: Permethrin Cream, 5% (Encube Ethicals) |
Who may qualify
- Ages
- 2 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, 2 years of age or older.
- If female and of childbearing potential, prepared to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., double barrier methods, intrauterine device (IUD), oral, transdermal or injected hormonal contraceptives). Female patients using hormonal contraceptives should have been on the same product/dosing regimen for at least 28 days before baseline and should not change this regimen during the study.
- Signed informed consent that meets all criteria of current FDA and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) regulations. For patients who are considered minors in the state the study is being conducted (< 18 years in most states) the parent or legal guardian should sign the consent form and the child will be required to sign a patient "assent" form, as appropriate. Patients 11-17 years of age will read and sign an Independent Review Board (IRB)-approved assent form and patients 6-10 years of age will provide verbal assent. Patients 2-5 years of age will be exempt from providing assent based on the child's comprehension and cognitive skills.
- Clinical diagnosis of active scabies by presence of a burrow and/or typical scabietic lesions at the classic sites of infestation.
- Parasitological confirmation of clinical diagnosis with demonstration under light microscope of mites and/or their products (larvae, eggs or fecal material).
Key exclusion criteria (16 listed)
- Patients who are pregnant, lactating, or planning to become pregnant during the study.
- Any systemic or dermatologic disorder that, in the opinion of the Investigator, will interfere with the study results or increase the risk of adverse events (AEs).
- Known hypersensitivity to permethrin cream or any of its components.
- Use of any systemic or topical acaricide or ectoparasiticide within one month before Screening.
- Patient has signs of a systemic infection or is receiving systemic therapy for an infectious disease.
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%Permethrin Cream 5% | Drug | Test: Permethrin Cream, 5% |
| Elimite™ Cream (permethrin) 5%Also: Elimite™ CreamPermethrin Cream 5% | Drug | Reference: Elimite™ Cream |
Primary outcome
Number of Patients in Each Treatment Group With Therapeutic Cure (Parasitological Cure Plus Clinical Cure) of Scabies
Time frame: Day 28 ± 4
Parasitological cure is defined as failure to demonstrate microscopically the presence of scabies infestation (i.e., no living mites, no viable mite eggs, and no mite fecal matter present). Clinical cure is defined as visual evidence of absence of new lesions and healing of original lesions, regardless the presence of post-scabietic nodules (i.e., post-scabietic nodules need not be considered as new lesions or persistence of old lesions).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- 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.
Pratik Kamani study director
Encube Ethicals Pvt. Ltd.
15 sites in 3 countries: 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™ Cream (permethrin) 5% in people with Scabies, run by Encube Ethicals Pvt. Ltd. at 15 sites in 3 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 7 inclusion and 16 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 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, El Salvador, 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. 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 14 Mar 2019). 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 Patients in Each Treatment Group With Therapeutic Cure (Parasitological Cure Plus Clinical Cure) of Scabies (time frame: Day 28 ± 4). 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 Mar 2019.