Head LicePhase 1NCT02062073
Dermal Safety Study to Evaluate the Sensitizing Potential of Abametapir Lotion
A Phase 1 study testing Abametapir Lotion 0.74% w/w, 0.1% sodium lauryl sulfate and saline 0.9% in people with Head Lice, run by Dr. Reddy's Laboratories Limited at 1 site in United States.
Trial summary
Purpose of this study will be to determine the potential of abametapir lotion to induce sensitization by repeated topical application to the healthy skin of humans under controlled conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head Lice
- What is being tested?
- Abametapir Lotion 0.74% w/w, 0.1% sodium lauryl sulfate and saline 0.9%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 238 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jun 2014
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are healthy (to be confirmed by medical history) males or females, 18 years of age or older;
- In the case of females of childbearing potential, are using an acceptable form of birth control (oral/implant/injectable/transdermal contraceptives, intrauterine device, condom with spermicide, diaphragm with spermicide, abstinence, partner's vasectomy). Abstinence or vasectomized partner are acceptable if the female subject agrees to implement one of the other acceptable methods of birth control if her lifestyle/partner changes;
- If female of childbearing potential, have a negative urine pregnancy test at Day 1, and are willing to submit to a pregnancy test at the end of study;
- Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events;
- Are of any skin type or race, providing the skin pigmentation will allow discernment of erythema;
- Complete a patch study Medical Screening form as well as a Medical Personal History form; and
- Read, understand, and provide signed informed consent.
Who cannot join
- Have any visible skin disease at the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction;
- Are not willing to refrain from using topical/systemic analgesics such as aspirin (daily use of 81 mg aspirin is acceptable), Aleve, Motrin, Advil, or Nuprin for 72 hours prior to and during the study (occasional use of acetaminophen will be permitted);
- Are using inhaled/systemic/topical corticosteroids in the 3 weeks prior to and during the study, or systemic/topical antihistamines for 72 hours prior to and during the study;
- Are using medication which, in the opinion of the investigative personnel, will interfere with the study results, including anti-inflammatory medications;
- Are unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions, or similar products on the back during the study;
- Have psoriasis and/or active atopic dermatitis/eczema;
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- Are females who are pregnant, plan to become pregnant during the study, or are breast-feeding a child;
- Have a known sensitivity to constituents present in the material being evaluated;
- Have damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site;
- Have received treatment for any type of internal cancer within 5 years prior to study entry;
- Have a history of, or are currently being treated for skin cancer;
- Are currently participating in any other clinical trial;
- Have any known sensitivity to adhesives; and/or
- Have received any investigational treatment(s) within 4 weeks prior to study entry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled Study to Evaluate the Sensitizing Potential of Abametapir Lotion in Healthy Volunteers Using a Repeat Insult Patch Test Design
Purpose of this study will be to determine the potential of abametapir lotion to induce sensitization by repeated topical application to the healthy skin of humans under controlled conditions.
- Conditions
- Head Lice
- Being tested
- Abametapir Lotion 0.74% w/w, 0.1% sodium lauryl sulfate, saline 0.9%, Vehicle Lotion
- Keywords
- head lice, Hatchtech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abametapir Lotion 0.74% w/wDrug
0.1% sodium lauryl sulfateOther
saline 0.9%Other
Vehicle LotionOther
| Study group | Role | What they receive |
|---|---|---|
| Abametapir Lotion 0.74% | Active comparator | 0.2 mL applied topically to the infrascapular area of the back under occlusive patch conditions 3 times weekly for 3 weeks, following with rest period and a challenge. Receives: Drug: Abametapir Lotion 0.74% w/w |
| Vehicle Lotion | Placebo comparator | 0.2 mL applied topically to the infrascapular area of the back under occlusive patch conditions 3 times weekly for 3 weeks, following with rest period and a challenge. Receives: Other: Vehicle Lotion |
| 0.1% sodium lauryl sulfate | Other | Concurrent control 0.2 mL applied topically to the infrascapular area of the back under occlusive patch conditions 3 times weekly for 3 weeks, following with rest period and a challenge. Receives: Other: 0.1% sodium lauryl sulfate |
| Saline 0.9% | Other | Concurrent control 0.2 mL applied topically to the infrascapular area of the back under occlusive patch conditions 3 times weekly for 3 weeks, following with rest period and a challenge. Receives: Other: saline 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the sensitizing potential of abametapir lotion using repeat insult patch test design
Evaluation of dermal reactions at the application sites will be assessed clinically using a visual scale that rates the degree of erythema, edema, and other signs of cutaneous irritation
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head LiceStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TKL Research, Inc., Accelovance
- Responsible party
- Sponsor
- Investigators
- Jonathan Dosik, Principal investigator, TKL Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062073
- Sponsor's protocol ID
- Ha03-006
- Status last verified
- Apr 2020
- First submitted
- 11 Feb 2014
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Study to Evaluate the Sensitizing Potential of Abametapir Lotion in Healthy Volunteers Using a Repeat Insult Patch Test Design
- ClinicalTrials.gov ID
- NCT02062073
- Acronym / sponsor ID
- Ha03-006
- Conditions
- Head Lice
- Keywords
- head lice, Hatchtech
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Collaborators
- TKL Research, Inc., Accelovance
- Study start
- Jan 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 13 Feb 2014 (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.
Purpose of this study will be to determine the potential of abametapir lotion to induce sensitization by repeated topical application to the healthy skin of humans under controlled conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Abametapir Lotion 0.74% | Active comparator | Drug: Abametapir Lotion 0.74% w/w0.2 mL applied topically to the infrascapular area of the back under occlusive patch conditions 3 times weekly for 3 weeks, following with rest period and a challenge. |
| Vehicle Lotion | Placebo comparator | Other: Vehicle Lotion0.2 mL applied topically to the infrascapular area of the back under occlusive patch conditions 3 times weekly for 3 weeks, following with rest period and a challenge. |
| 0.1% sodium lauryl sulfate | Other | Other: 0.1% sodium lauryl sulfateConcurrent control 0.2 mL applied topically to the infrascapular area of the back under occlusive patch conditions 3 times weekly for 3 weeks, following with rest period and a challenge. |
| Saline 0.9% | Other | Other: saline 0.9%Concurrent control 0.2 mL applied topically to the infrascapular area of the back under occlusive patch conditions 3 times weekly for 3 weeks, following with rest period and a challenge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are healthy (to be confirmed by medical history) males or females, 18 years of age or older;
- In the case of females of childbearing potential, are using an acceptable form of birth control (oral/implant/injectable/transdermal contraceptives, intrauterine device, condom with spermicide, diaphragm with spermicide, abstinence, partner's vasectomy). Abstinence or vasectomized partner are acceptable if the female subject agrees to implement one of the other acceptable methods of birth control if her lifestyle/partner changes;
- If female of childbearing potential, have a negative urine pregnancy test at Day 1, and are willing to submit to a pregnancy test at the end of study;
- Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events;
- Are of any skin type or race, providing the skin pigmentation will allow discernment of erythema;
Key exclusion criteria (14 listed)
- Have any visible skin disease at the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction;
- Are not willing to refrain from using topical/systemic analgesics such as aspirin (daily use of 81 mg aspirin is acceptable), Aleve, Motrin, Advil, or Nuprin for 72 hours prior to and during the study (occasional use of acetaminophen will be permitted);
- Are using inhaled/systemic/topical corticosteroids in the 3 weeks prior to and during the study, or systemic/topical antihistamines for 72 hours prior to and during the study;
- Are using medication which, in the opinion of the investigative personnel, will interfere with the study results, including anti-inflammatory medications;
- Are unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions, or similar products on the back during 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 |
|---|---|---|
| Abametapir Lotion 0.74% w/w | Drug | Abametapir Lotion 0.74% |
| 0.1% sodium lauryl sulfate | Other | 0.1% sodium lauryl sulfate |
| saline 0.9% | Other | Saline 0.9% |
| Vehicle Lotion | Other | Vehicle Lotion |
Primary outcome
to evaluate the sensitizing potential of abametapir lotion using repeat insult patch test design
Time frame: 8 weeks
Evaluation of dermal reactions at the application sites will be assessed clinically using a visual scale that rates the degree of erythema, edema, and other signs of cutaneous irritation
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 29 Apr 2020.
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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.
Jonathan Dosik principal investigator
TKL Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Abametapir Lotion 0.74% w/w, 0.1% sodium lauryl sulfate and saline 0.9% in people with Head Lice, run by Dr. Reddy's Laboratories Limited at 1 site 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 14 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 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
to evaluate the sensitizing potential of abametapir lotion using repeat insult patch test design (time frame: 8 weeks). 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 29 Apr 2020.