ScabiesPhase 3NCT02572986
A Study to Evaluate the Therapeutic Equivalence of Generic Permethrin Cream 5% to Elimite® in the Treatment of Scabies
A Phase 3 study testing Permethrin in people with Scabies, run by Dr. Reddy's Laboratories Limited at 13 sites in 3 countries.
Trial summary
Scabies is an infestation of the skin by the human itch mite (Sarcoptes scabiei). Diagnosis of scabies is made based on clinical symptoms, such as nocturnal itching, and appearance and distribution of the rash. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 13 sitesin 3 countries
- Study dates
- Sep 2015to Aug 2016
- Phase
- Phase 3
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed Informed Consent that meets all criteria of current FDA regulations.
- Male or non-pregnant, non-lactating female at least 2 years of age or older.
- 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.
- Women must be either 1 year post-menopausal (no menstrual periods for at least 12 months), surgically sterile, or if they are of child-bearing potential, they must:
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- Have been using systemic birth control, intrauterine device, or used barrier methods such as diaphragm plus spermicide or condom plus spermicide consistently, at least 14 days before study cream administration.
- Had a normal menstrual cycle for the month before start of treatment.
- Have a negative urine pregnancy test result upon entry into the study.
- Agree to use a medically accepted form of birth control (oral, implant, injectable or transdermal contraceptives, intrauterine device, condom plus spermicide, diaphragm plus spermicide) or practice abstinence throughout the study period.
- Free from 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.
- Ability to apply study product to self or to other person if a child. If patient is a child, then parent/guardian will apply study product to him/her.
Who cannot join
- Known hypersensitivity to permethrin cream or any of its components, ragweed or chrysanthemums, synthetic pyrethroids or pyrethrin.
- Use of any systemic or topical acaricide 1 month before enrollment.
- Patients with crusted/Norwegian scabies.
- 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.
- Women who are pregnant, planning pregnancy or lactating.
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- 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.
- Patients less than 2 years of age.
- Patients or guardians of patients, who are unable or unwilling to give informed consent or assent respectively.
- Receipt of any drug as part of a research study within 30 days before screening.
- History of seizures.
- 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.
- Treatment with systemic or topical corticosteroids less than 2 weeks and less than 1 week from enrollment, respectively.
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
United States10 sites
Sun Rise Clinical Research, Inc
Bell Gardens, California, 90201
Derm Dx Center for Dermatology
Hazleton, Pennsylvania, 18201
Solutions Through Advanced Research
Jacksonville, Florida, 32258
San Marcus Research Clinic, Incorporation
Miami, Florida, 33015
L & C Professional Medical Research Institute
Miami, Florida, 33144
Vista Health Research, LLC
Miami, Florida, 33176
Havana Research Institute
Pasadena, California, 91105
Omni Dermatology
Phoenix, Arizona, 85018
Zain Research, LLC
Richland, Washington, 99352
Sun Research Institute
San Antonio, Texas, 78215
El Salvador2 sites
Clinica Dermatologica
San Salvador
Clinica Dermatologica y Cirugia de Piel
Santa Tecla, La Libertad
Panama1 site
Clinica Dermatologica Dra. Yariela Grajales
Panama City, PanamaCity
About this study
Official title: A Randomized, Double-Blind, Parallel-Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Permethrin Cream, 5% to Elimite™ Cream 5% in the Treatment of Scabies
Scabies is an infestation of the skin by the human itch mite (Sarcoptes scabiei). Diagnosis of scabies is made based on clinical symptoms, such as nocturnal itching, and appearance and distribution of the rash. Definitive diagnosis includes the microscopic identification of the mite, mite eggs, or mite fecal matter in the skin. Topical permethrin is considered the drug of choice for the treatment of scabies. It is a synthetic pyrethroid that is safe for use in adults and children 2 months and older.
This study will evaluate the therapeutic equivalence of a generic permethrin cream 5% to Elimite® in the Treatment of Scabies.
- Conditions
- Scabies
- Being tested
- Permethrin
- Medical subject headings
- Scabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PermethrinDrug
| Study group | Role | What they receive |
|---|---|---|
| Permethrin cream 5% | Experimental | Manufactured by Dr. Reddy's Laboratories, Ltd Receives: Drug: Permethrin |
| Elimite™ Cream (permethrin) 5% | Active comparator | Manufactured by Prestium Pharma, Inc Receives: Drug: Permethrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with therapeutic cure (parasitological cure plus clinical cure) of scabies
Measured: Day 28
Secondary outcomes (1)
The proportion of patients with no itch persistence
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novum Pharmaceutical Research Services
- Responsible party
- Sponsor
- Investigators
- Ashis Patnaik, MD, Study director, Dr. Reddy's Laboratories LimitedPrasanna Ganapathi, MD, Study director, Dr. Reddy's Laboratories LimitedShilpi Dhawan, MD, Study director, Dr. Reddy's Laboratories Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572986
- Sponsor's protocol ID
- DRL-USG02-P/2015
- Status last verified
- Oct 2015
- First submitted
- 8 Oct 2015
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. 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% to Elimite™ Cream 5% in the Treatment of Scabies
- ClinicalTrials.gov ID
- NCT02572986
- Acronym / sponsor ID
- DRL-USG02-P/2015
- Conditions
- Scabies
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Novum Pharmaceutical Research Services
- Study start
- Sep 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 9 Oct 2015 (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.
Scabies is an infestation of the skin by the human itch mite (Sarcoptes scabiei). Diagnosis of scabies is made based on clinical symptoms, such as nocturnal itching, and appearance and distribution of the rash. Definitive diagnosis includes the microscopic identification of the mite, mite eggs, or mite fecal matter in the skin. Topical permethrin is considered the drug of choice for the treatment of scabies. It is a synthetic pyrethroid that is safe for use in adults and children 2 months and older.
This study will evaluate the therapeutic equivalence of a generic permethrin cream 5% to Elimite® in the Treatment of 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
| Arm | Type | Receives |
|---|---|---|
| Permethrin cream 5% | Experimental | Drug: PermethrinManufactured by Dr. Reddy's Laboratories, Ltd |
| Elimite™ Cream (permethrin) 5% | Active comparator | Drug: PermethrinManufactured by Prestium Pharma, Inc |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Signed Informed Consent that meets all criteria of current FDA regulations.
- Male or non-pregnant, non-lactating female at least 2 years of age or older.
- 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.
Key exclusion criteria (15 listed)
- Known hypersensitivity to permethrin cream or any of its components, ragweed or chrysanthemums, synthetic pyrethroids or pyrethrin.
- Use of any systemic or topical acaricide 1 month before enrollment.
- Patients with crusted/Norwegian scabies.
- 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.
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 | Drug | Elimite™ Cream (permethrin) 5%, Permethrin cream 5% |
Primary outcome
Proportion of patients with therapeutic cure (parasitological cure plus clinical cure) of scabies
Time frame: Day 28
1 secondary outcome
The proportion of patients with no itch persistence
Time frame: Day 28
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 Oct 2016.
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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.
Ashis Patnaik, MD study director
Dr. Reddy's Laboratories Limited
Prasanna Ganapathi, MD study director
Dr. Reddy's Laboratories Limited
Shilpi Dhawan, MD study director
Dr. Reddy's Laboratories Limited
13 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 in people with Scabies, run by Dr. Reddy's Laboratories Limited at 13 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 12 inclusion and 15 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 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, El Salvador, Panama. 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?
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?
Proportion of patients with therapeutic cure (parasitological cure plus clinical cure) of scabies (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 14 Oct 2016.