ScabiesPhase 3NCT03973775
A Bioequivalence Study With Clinical Endpoints to Evaluate the Safety and Therapeutic Equivalence of Permethrin Cream 5% & Elimite™ in Subjects With Scabies
A Phase 3 study testing Permethrin Cream 5% in people with Scabies, run by Saptalis Pharmaceuticals LLC at 5 sites in United States.
Trial summary
This phase III study was conducted to establish the clinical bioequivalence of Permethrin Cream 5% and Elimite™ in the treatment of scabies following a single application. Read more about this study
- Who is it for?
- Ages 2 months to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Scabies
- What is being tested?
- Permethrin Cream 5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 5 sitesUnited States
- Study dates
- 10 Apr 2018to 6 Dec 2018
- 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 months to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subjects and/or parent/guardian must have understood and signed appropriately administered informed consent/assent in their own language
- Healthy male and non-pregnant/non-lactating female subjects aged 2 months to 65 years diagnosed with scabies
- Must have dermatological evidence of active scabies (burrows, erythematous papules, etc.) confirmed by recovery of live Sarcoptes scabiei (the Principal investigator or trained and experienced Study Team examines the specimen(s) under magnification to verify the identity and viability of the scabies mite, ova, or mite feces at the site)
- The youngest subject (with scabies infestation as defined above) from each household is considered the index or primary subject of the household for evaluation of the primary endpoint. Other members of the household and close contacts are enrolled in the study as Secondary subjects and evaluated for all safety parameters (not included in primary endpoint analysis). Secondary subjects that are confirmed to have dermatological evidence of scabies should receive the same study treatment as the Index subject
- Must be available and willing to report for follow up visits
- Is otherwise healthy, well-nourished, non-febrile and not suffering from an infection likely to require systemic antibiotic or topical therapy. These criteria will be ascertained during screening by the Principal investigator
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- Must agree not to use other scabicides or other medications likely to affect the evaluation of their response to scabies treatment
- If female of childbearing potential, willing to use an acceptable method of birth control, should be stable for 3 months prior to screening and throughout the study
- Must be willing to follow the procedures to decrease infestation: Clothes and bed linens that were in contact with the subjects, their household members and close contacts during the previous 48 to 72 hours will be machine washed at 60°C and machine dried the day after the first treatment. For materials that cannot be laundered, insecticide powder or aerosolized insecticide may be used, or the items may be kept in a sealed bag for at least 48 to 72 hours.
Who cannot join
- Subject or parent/guardian has not signed informed consent/assent
- Pregnant females, lactating females or females planning for a pregnancy
- Females of childbearing potential who do not agree to utilize an adequate method of contraception
- Known history of irritation or sensitivity to parasiticides
- Skin conditions that could make it difficult to evaluate the extent of an infestation or would present a problem in the evaluation of response to therapy (e.g. atopic dermatitis, eczema, contact dermatitis, lichen planus, papular urticaria, seborrheic dermatitis).
- Use within 4 weeks of baseline visit (1) immunomodulators (2) systemic medications that suppress the immune system (3) topical or oral parasiticides.
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- Use within 2 weeks of baseline visit (1) topical steroids (2) topical or systemic antibiotics
- Has crusted scabies • Known allergy or hypersensitivity to permethrin, any synthetic pyrethroid or pyrethrin, plants in the Asteraceae/Compositae family (e.g. chrysanthemums, ragweed, marigolds, and daisies)
- Subjects whose household members and close contacts refuse treatment.
- Subjects with greater than 5 infested household members and close contacts
- Subjects whose sexual contacts do not agree to restrict prolonged skin to skin contact with non-household members during the study period
- Subjects with a household member less than 2 months of age
- Suffers from a renal or hepatic impairment
- Has been treated for scabies by any form of scabies treatment whether prescription, over-the-counter or a home remedy within a month prior to their screening visit
- Had received or used an investigational new drug within the month immediately preceding the screening
- Is receiving any medication likely to mask or modify scabies
- Will not be available for follow up visits
- Has other cutaneous conditions which might be confused with scabies
- Seriously immune suppressed subjects
- Has been previously empaneled in this study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Universal Biopharma Research Institute Inc.
Dinuba, California, 93618
West Houston Clinical Research Service
Houston, Texas, 77055
Long Beach Clinical Trials Services, Inc.
Long Beach, California, 90806
SouthCoast Research Center, Inc (Clinical Site & Drug Shipment Facility)
Miami, Florida, 33136
Havana Research Institute
Pasadena, California, 91105
About this study
Official title: A Double Blind, Two Arm, Multicenter, Randomized, Parallel Group, Bioequivalence Study With Clinical Endpoints to Evaluate the Safety and Therapeutic Equivalence of Permethrin Cream 5% & Elimite™ in Subjects With Scabies
This phase III study was conducted to establish the clinical bioequivalence of Permethrin Cream 5% and Elimite™ in the treatment of scabies following a single application.
Read the detailed description
A Double Blind, Two Arm, Multicenter, Randomized, Parallel Group Bioequivalence Study with Clinical Endpoints to Evaluate the Safety and Therapeutic Equivalence of, Permethrin Cream 5% (Manufactured by Saptalis Pharmaceuticals, LLC) \& Elimite™ (Permethrin Cream 5%, manufactured for Prestium Pharma, Inc.) in Subjects with Scabies.
The objectives of this study are:
Primary Objective: To establish the clinical bioequivalence of Permethrin Cream 5% (manufactured by Saptalis Pharmaceuticals, LLC) and Elimite™ (Permethrin Cream 5%, manufactured for Prestium Pharma, Inc.) in the treatment of scabies (Sarcoptes scabiei) following a single application.
Secondary Objective: To compare the safety and tolerability between the study drugs.
- Conditions
- Scabies
- Being tested
- Permethrin Cream 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
Patients will be assigned to the test product Permethrin Cream 5% to the Reference Listed Drug Product Elimite cream.
| Study group | Role | What they receive |
|---|---|---|
| Test Drug Treatment Arm | Experimental | Permethrin Cream 5%, Saptalis Pharmaceuticals, LLC Receives: Drug: Permethrin Cream 5% |
| Reference Drug Treatment Arm | Active comparator | Elimite™ (Permethrin Cream 5%), Prestium Pharma, Inc. Receives: Drug: Permethrin Cream 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the proportion of index subjects in the Per Protocol (PP) population in each treatment group with treatment cure when examined at Visit 4 (Day 28 ± 2 Days).
Cure is defined as demonstration of clinical cure (all clinical findings have completely resolved, including inflammatory/non-inflammatory lesions) and microscopic cure (demonstration of the absence of mites, ova, and/or mite feces) on Day 28. Negative microscopy can be declared if no mites, ova, or mite feces is found from a minimum of 3 skin scrapings from previously affected sites.
Measured: Day 28 ± 2 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start10 Apr 2018
- Primary completion13 Nov 2018
- Study completion6 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saptalis Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- bioRASI, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973775
- Sponsor's protocol ID
- SP-2992
- Status last verified
- Oct 2020
- First submitted
- 30 May 2019
- Last updated
- 23 Oct 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Goldust M, Babae Nejad S, Rezaee E, Raghifar R. Comparative trial of permethrin 5% versus lindane 1% for the treatment of scabies. J Dermatolog Treat. 2013 Jan 20. doi: 10.3109/09546634.2012.723122. Online ahead of print.
PubMed 22905702Oliva ME, Rekha A, Yellin A, Pasternak J, Campos M, Rose GM, Babinchak T, Ellis-Grosse EJ, Loh E; 301 Study Group. A multicenter trial of the efficacy and safety of tigecycline versus imipenem/cilastatin in patients with complicated intra-abdominal infections [Study ID Numbers: 3074A1-301-WW; ClinicalTrials.gov Identifier: NCT00081744]. BMC Infect Dis. 2005 Oct 19;5:88. doi: 10.1186/1471-2334-5-88.
PubMed 16236177
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Two Arm, Multicenter, Randomized, Parallel Group, Bioequivalence Study With Clinical Endpoints to Evaluate the Safety and Therapeutic Equivalence of Permethrin Cream 5% & Elimite™ in Subjects With Scabies
- ClinicalTrials.gov ID
- NCT03973775
- Acronym / sponsor ID
- SP-2992
- Conditions
- Scabies
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Saptalis Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Collaborators
- bioRASI, LLC
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 13 Nov 2018 (actual)
- Study completion
- 6 Dec 2018 (actual)
- First posted
- 4 Jun 2019 (actual)
- 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.
This phase III study was conducted to establish the clinical bioequivalence of Permethrin Cream 5% and Elimite™ in the treatment of scabies following a single application.
Detailed description
A Double Blind, Two Arm, Multicenter, Randomized, Parallel Group Bioequivalence Study with Clinical Endpoints to Evaluate the Safety and Therapeutic Equivalence of, Permethrin Cream 5% (Manufactured by Saptalis Pharmaceuticals, LLC) \& Elimite™ (Permethrin Cream 5%, manufactured for Prestium Pharma, Inc.) in Subjects with Scabies.
The objectives of this study are:
Primary Objective: To establish the clinical bioequivalence of Permethrin Cream 5% (manufactured by Saptalis Pharmaceuticals, LLC) and Elimite™ (Permethrin Cream 5%, manufactured for Prestium Pharma, Inc.) in the treatment of scabies (Sarcoptes scabiei) following a single application.
Secondary Objective: To compare the safety and tolerability between the study drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Drug Treatment Arm | Experimental | Drug: Permethrin Cream 5%Permethrin Cream 5%, Saptalis Pharmaceuticals, LLC |
| Reference Drug Treatment Arm | Active comparator | Drug: Permethrin Cream 5%Elimite™ (Permethrin Cream 5%), Prestium Pharma, Inc. |
Who may qualify
- Ages
- 2 months to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects and/or parent/guardian must have understood and signed appropriately administered informed consent/assent in their own language
- Healthy male and non-pregnant/non-lactating female subjects aged 2 months to 65 years diagnosed with scabies
- Must have dermatological evidence of active scabies (burrows, erythematous papules, etc.) confirmed by recovery of live Sarcoptes scabiei (the Principal investigator or trained and experienced Study Team examines the specimen(s) under magnification to verify the identity and viability of the scabies mite, ova, or mite feces at the site)
- The youngest subject (with scabies infestation as defined above) from each household is considered the index or primary subject of the household for evaluation of the primary endpoint. Other members of the household and close contacts are enrolled in the study as Secondary subjects and evaluated for all safety parameters (not included in primary endpoint analysis). Secondary subjects that are confirmed to have dermatological evidence of scabies should receive the same study treatment as the Index subject
- Must be available and willing to report for follow up visits
Key exclusion criteria (20 listed)
- Subject or parent/guardian has not signed informed consent/assent
- Pregnant females, lactating females or females planning for a pregnancy
- Females of childbearing potential who do not agree to utilize an adequate method of contraception
- Known history of irritation or sensitivity to parasiticides
- Skin conditions that could make it difficult to evaluate the extent of an infestation or would present a problem in the evaluation of response to therapy (e.g. atopic dermatitis, eczema, contact dermatitis, lichen planus, papular urticaria, seborrheic dermatitis).
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%Patients will be assigned to the test product Permethrin Cream 5% to the Reference Listed Drug Product Elimite cream. | Drug | Reference Drug Treatment Arm, Test Drug Treatment Arm |
Primary outcome
The primary endpoint is the proportion of index subjects in the Per Protocol (PP) population in each treatment group with treatment cure when examined at Visit 4 (Day 28 ± 2 Days).
Time frame: Day 28 ± 2 Days
Cure is defined as demonstration of clinical cure (all clinical findings have completely resolved, including inflammatory/non-inflammatory lesions) and microscopic cure (demonstration of the absence of mites, ova, and/or mite feces) on Day 28. Negative microscopy can be declared if no mites, ova, or mite feces is found from a minimum of 3 skin scrapings from previously affected sites.
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 23 Oct 2020.
- Background: PubMed 22905702Goldust M, Babae Nejad S, Rezaee E, Raghifar R. Comparative trial of permethrin 5% versus lindane 1% for the treatment of scabies. J Dermatolog Treat. 2013 Jan 20. doi: 10.3109/09546634.2012.723122. Online ahead of print.
- Background: PubMed 16236177Oliva ME, Rekha A, Yellin A, Pasternak J, Campos M, Rose GM, Babinchak T, Ellis-Grosse EJ, Loh E; 301 Study Group. A multicenter trial of the efficacy and safety of tigecycline versus imipenem/cilastatin in patients with complicated intra-abdominal infections [Study ID Numbers: 3074A1-301-WW; ClinicalTrials.gov Identifier: NCT00081744]. BMC Infect Dis. 2005 Oct 19;5:88. doi: 10.1186/1471-2334-5-88.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Cochrane Review PDFLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 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% in people with Scabies, run by Saptalis Pharmaceuticals LLC at 5 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 9 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 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
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?
The primary endpoint is the proportion of index subjects in the Per Protocol (PP) population in each treatment group with treatment cure when examined at Visit 4 (Day 28 ± 2 Days). (time frame: Day 28 ± 2 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03973775, which also lists 2 linked publications.
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 23 Oct 2020.