Scabies
Conditions
Brief summary
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: 1. 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. 2. Compare the safety of Test and Reference treatments in patients with scabies.
Interventions
Permethrin Cream 5%
DRUGElimite™ Cream (permethrin) 5%
Permethrin Cream 5%
Sponsors
Novum Pharmaceutical Research Services
Encube Ethicals Pvt. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The study product will be randomized, packaged and blinded so that the packaging for both treatments look identical.
Intervention model description
Patients will be assigned to the test or reference permethrin to treat scabies.
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or non-pregnant, non-lactating female, 2 years of age or older. 2. 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. 3. 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. 4. Clinical diagnosis of active scabies by presence of a burrow and/or typical scabietic lesions at the classic sites of infestation. 5. Parasitological confirmation of clinical diagnosis with demonstration under light microscope of mites and/or their products (larvae, eggs or fecal material). 6. Symptom score of 2 or 3 on a 4-point rating scale of 0-3 for nocturnal itching/pruritus. 7. 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.
Exclusion criteria
1. Patients who are pregnant, lactating, or planning to become pregnant during the study. 2. 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). 3. Known hypersensitivity to permethrin cream or any of its components. 4. Use of any systemic or topical acaricide or ectoparasiticide within one month before Screening. 5. Patient has signs of a systemic infection or is receiving systemic therapy for an infectious disease. 6. 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. 7. Patients with an underlying immunodeficient state (including prolonged treatment with corticosteroids), immunosuppressive disorders requiring therapy, severe systemic disease and history of HIV infection. 8. Any condition, medical, psychological, or social, that, in the Investigator's opinion, would interfere with participation in the study. 9. Family members of employees of the clinic or Investigator. 10. Patients who, in the opinion of the Investigator, would be non-compliant with the requirements of the study protocol. 11. Patients whose close personal contacts will not or are not willing to comply with standard of care for Scabies management. 12. Receipt of any drug as part of a research study within 30 days before Screening. 13. History of seizures. 14. Use of systemic corticosteroids within two weeks before Screening. 15. Use of topical corticosteroids within one week before Screening. 16. Previous participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients in Each Treatment Group With Therapeutic Cure (Parasitological Cure Plus Clinical Cure) of Scabies | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With a Therapeutic Cure That Completed Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 4 Days. | Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 4 Days | 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). |
| Number of Patients With a Therapeutic Cure That Completed Visit 2 Within 14 ± 2 Days and Visit 3 Between Day 26 and Day 32, Inclusive. | Visit 2 within 14 ± 2 days and Visit 3 between Day 26 and Day 32, inclusive. | 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). |
| Number of Patients With a Therapeutic Cure That Completed Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 2 Days. | Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 2 Days | 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). |
Countries
El Salvador, Puerto Rico, United States
Participant flow
Recruitment details
Two hundred fifty-four (254) patients were randomized to study products. Thirteen (13) sites randomized patients into the study.The first patient was enrolled on 06/14/2017 and the last patient completed was on 10/30/2017. The time from first patient enrolled until last patient completed was approximately four months.
Pre-assignment details
All eligible patients were randomized at visit 1 and received the study product with instructions for dosing at home.
Participants by arm
| Arm | Count |
|---|---|
| Reference: Elimite™ Cream Reference: Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.)
Elimite™ Cream (permethrin) 5%: Permethrin Cream 5% | 129 |
| Test: Permethrin Cream, 5% Test: Permethrin Cream, 5% (Encube Ethicals)
Permethrin Cream, 5%: Permethrin Cream 5% | 125 |
| Total | 254 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Test: Permethrin Cream, 5% | Total | Reference: Elimite™ Cream |
|---|---|---|---|
| Age, Continuous | 37.7 years STANDARD_DEVIATION 22.4 | 39.2 years STANDARD_DEVIATION 21.8 | 40.7 years STANDARD_DEVIATION 21.2 |
| Baseline Severity of Lesion Count Infestation Pretreatment Mild | 45 Participants | 92 Participants | 47 Participants |
| Baseline Severity of Lesion Count Infestation Pretreatment Moderate | 57 Participants | 125 Participants | 68 Participants |
| Baseline Severity of Lesion Count Infestation Pretreatment Severe | 23 Participants | 37 Participants | 14 Participants |
| Baseline Severity Score of Nocturnal Itching Pretreatment Mild | 0 Participants | 0 Participants | 0 Participants |
| Baseline Severity Score of Nocturnal Itching Pretreatment Moderate | 110 Participants | 222 Participants | 112 Participants |
| Baseline Severity Score of Nocturnal Itching Pretreatment None | 0 Participants | 0 Participants | 0 Participants |
| Baseline Severity Score of Nocturnal Itching Pretreatment Severe | 15 Participants | 32 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 97 Participants | 193 Participants | 96 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 61 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 29 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 108 Participants | 217 Participants | 109 Participants |
| Region of Enrollment El Salvador | 62 participants | 125 participants | 63 participants |
| Region of Enrollment Puerto Rico | 6 participants | 12 participants | 6 participants |
| Region of Enrollment United States | 57 participants | 117 participants | 60 participants |
| Sex: Female, Male Female | 73 Participants | 145 Participants | 72 Participants |
| Sex: Female, Male Male | 52 Participants | 109 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 129 | 0 / 125 |
| other Total, other adverse events | 7 / 129 | 7 / 125 |
| serious Total, serious adverse events | 0 / 129 | 1 / 125 |
Outcome results
Primary
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).
Time frame: Day 28 ± 4
Population: The Per Protocol (PP) population was used for the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Reference: Elimite™ Cream | Number of Patients in Each Treatment Group With Therapeutic Cure (Parasitological Cure Plus Clinical Cure) of Scabies | 83 Participants |
| Test: Permethrin Cream, 5% | Number of Patients in Each Treatment Group With Therapeutic Cure (Parasitological Cure Plus Clinical Cure) of Scabies | 86 Participants |
Other Pre-specified
Number of Patients With a Therapeutic Cure That Completed Visit 2 Within 14 ± 2 Days and Visit 3 Between Day 26 and Day 32, Inclusive.
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).
Time frame: Visit 2 within 14 ± 2 days and Visit 3 between Day 26 and Day 32, inclusive.
Population: Number of patients with a Therapeutic Cure that completed Visit 2 within 14 ± 2 days and Visit 3 between Day 26 and Day 32, inclusive.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Reference: Elimite™ Cream | Number of Patients With a Therapeutic Cure That Completed Visit 2 Within 14 ± 2 Days and Visit 3 Between Day 26 and Day 32, Inclusive. | 68 Participants |
| Test: Permethrin Cream, 5% | Number of Patients With a Therapeutic Cure That Completed Visit 2 Within 14 ± 2 Days and Visit 3 Between Day 26 and Day 32, Inclusive. | 75 Participants |
Other Pre-specified
Number of Patients With a Therapeutic Cure That Completed Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 2 Days.
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).
Time frame: Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 2 Days
Population: Patients who completed Visit 2 within 14 ± 2 days and Visit 3 within 28 ± 2 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Reference: Elimite™ Cream | Number of Patients With a Therapeutic Cure That Completed Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 2 Days. | 65 Participants |
| Test: Permethrin Cream, 5% | Number of Patients With a Therapeutic Cure That Completed Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 2 Days. | 73 Participants |
Other Pre-specified
Number of Patients With a Therapeutic Cure That Completed Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 4 Days.
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).
Time frame: Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 4 Days
Population: Patients who completed Visit 2 within 14 ± 2 days and Visit 3 within 28 ± 4 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Reference: Elimite™ Cream | Number of Patients With a Therapeutic Cure That Completed Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 4 Days. | 77 Participants |
| Test: Permethrin Cream, 5% | Number of Patients With a Therapeutic Cure That Completed Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 4 Days. | 81 Participants |