Head LiceNCT06333054
Safety and Efficacy of a Head Lice Shampoo
A study testing Pyrethrum Extract in people with Head Lice, run by Oystershell NV at 1 site in Germany.
Trial summary
This study is designed to compare the effectiveness and safety of test head lice shampoo (Test product) versus Goldgeist® Forte (reference product) following two applications. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Head Lice
- What is being tested?
- Pyrethrum Extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteGermany
- Study dates
- 13 Oct 2014to 8 Jun 2015
- Phase
- Interventional
- 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 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Gender: male/female
- Age: ≥ 1 year of age at the time of signing the informed consent
- Patients with active head lice infestation of at least 5 living lice and 5 apparently living eggs
- Patient or his/her guardian must be capable of understanding and providing written informed consent
- The patient or his/her legal representative must give written informed consent, after having been oral and written informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the subjects participating in the study
- Patients must agree to not use any other ant-lice treatment for the duration of the study
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- Female patients:
- are women of childbearing potential who test negative for pregnancy and agree to use a reliable method of birth control or remain abstinent duringthe study. Methods of contraception considered acceptable include oral contraceptives, contraceptive patch, intrauterine device, vaginal ring, diaphragm with contraceptive gel, or condom with contraceptive gel
- or are women of non-childbearing potential, defined as: women who have had surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation),
- or women who are ≥ 60 years of age.
Who cannot join
- Known allergic reactions or hypersensitivity to the active ingredients used or the constituents
- Patients with known skin allergies, multiple drug allergies or multiple allergies to cosmetic products
- Pregnant or breast feeding women
- Patient underwent treatment with any form of head lice treatment within the last 30 days prior to the Screening Visit (day 0)
- Patients with chronic scalp disorder
- Individuals on systemic or topical drugs or medications, including systemic antibiotics, which in the opinion of the investigative personnel may interfere with the study results
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- Subjects with hair longer than mid-back
- Patients suspected or known not to follow instructions
- Patients or his/her legal representative who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study
- Previous participation in this study or participation in any other investigational trial within the preceding 30 days
- The patients are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- The patients are Oystershell employees or are employees of third-party organizations involved in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Controlled, Investigator Blinded, Comparative Study to Evaluate the Safety and Efficacy of a Head Lice Shampoo.
This study is designed to compare the effectiveness and safety of test head lice shampoo (Test product) versus Goldgeist® Forte (reference product) following two applications.
Read the detailed description
The primary objective was to show, that the cure rate after local application of Test head lice shampoo is better than a predefined limit. It had to be shown, that the Test head lice shampoo achieved a cure rate superior to 70% (cure rate at the end of day 10, corrected for re-infestation).
- Conditions
- Head Lice
- Being tested
- Pyrethrum Extract, Silcap Shampoo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyrethrum ExtractDrug
Treatment with Goldgeist® Forte
Silcap ShampooDevice
Also called Paranix
Treatment with Silcap Shampoo
| Study group | Role | What they receive |
|---|---|---|
| Silcap Shampoo | Experimental | Subjects with head lice were treated with Silcap Shampoo at visit 1 (day 0) and at visit 3 (day 7). Receives: Device: Silcap Shampoo |
| Goldgeist® Forte | Active comparator | Subjects with head lice were treated with Goldgeist® Forte at visit 1 (day 0) and at visit 3 (day 7). Receives: Drug: Pyrethrum Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure Rate superior to 70% for the test product
The primary objective was to show, that the cure rate after local application of Test head lice shampoo is better than a predefined limit. It had to be shown, that the Test head lice shampoo achieved a cure rate superior to 70% (cure rate at the end of day 10, corrected for re-infestation).
Measured: Day 10
Secondary outcomes (9)
Cure Rate superior to 70% for the reference product
The secondary objective was the comparison of the cure rate of the test product with the reference product by using different endpoints. It should be shown that the cure rate on day 10 for the reference product for all baseline infestations is better than the pre-defined limit of 70%.
Measured: Day 10
Superior cure rate to the reference
The secondary objective was the comparison of the cure rate of the test product with the reference product by using different endpoints. It should be shown that the test head lice shampoo has a cure rate superior to the reference.
Measured: Day 10
Non-inferiority rate to the reference
The secondary objective was the comparison of the cure rate of the test product with the reference product by using different endpoints. It should be shown that in case, that superiority could not be shown, the test head lice shampoo is at least not-inferior to the reference. A non-inferiority margin of 7.5% was defined.
Measured: Day 10
Local tolerability
Subjective symptoms (burning, paraesthesia, pruritus) after administration of the investigational products were rated by the patients on a 4-category scale on day 0 and day 7 (0h, 1h p.a.) directly after study drug application as well as on day 1 and day 10 p.a.:
Score 1 = no Score 2 = mild Score 3 = moderate Score 4 = severe
Measured: Day 0 (at start and after treatment), Day 1, Day 7 (at start and after treatment), Day 10
Global tolerability
Global tolerability was assessed by blinded study staff and by the patient or his/her guardian at day 10. The study staff performed the rating in each case prior to the assessment by the patient to avoid bias. Afterwards, the patient self-assessed the global tolerability.
The global tolerability was rated on a 4-category scale with:
Score 1 = very good Score 2 = good Score 3 = moderate Score 4 = poor
Measured: Day 10
Skin irritation assessment
To investigate a potential irritation of the eyes due to the treatment, the trained and blinded study staff assessed the severity of redness of both eyes within 1 hour before first treatment (baseline), as well as directly after study drug application and after the end of treatment on study day 0, day 1, day 7 (pre-treatment, 0h and 1h p.a.) and on day 10.
For the assessment of eyes the following 4-category scale as mentioned above were used.
Score 1 = no Score 2 = mild Score 3 = moderate Score 4 = severe
Measured: Day 0 (before, at start and after treatment),Day 1, Day 7 (before, at start and after treatment), Day 10
Eye irritation assessment
Skin irritation (secondary infection, erythema, excoriation) was assessed by blinded and trained study staff within 1 hour before first treatment (baseline), as well as directly after study drug application and after the end of treatment on study day 0, day 1, day 7 (pre-treatment, 0h and 1h p.a.) and on day 10 .
For the assessment of skin irritation the following 4-category scale as mentioned above were used.
Score 1 = no Score 2 = mild Score 3 = moderate Score 4 = severe
Measured: Day 0 (before, at start and after treatment),Day 1, Day 7 (before, at start and after treatment), Day 10
Esthetical effect of the anti-lice products
The esthetical properties of the investigational products were evaluated to determine the satisfaction by the patients with the product after application using a questionnaire about hair and scalp feeling, greasiness, hair look, shininess and volume. The questioning was performed on day 0 and day 7 after treatment and drying the hair.
Six questions al with Score 1-4:
Score 1 = strongly agree Score 2 = agree Score 3 = disagree Score 4 = strongly disagree
Measured: Day 0 (after treatment); day 7 (after treatment)
Adverse Events (AEs)
An Adverse Event (AE) is any unintended or unfavourable sign (including an abnormal finding), symptom or disease occurring in a subject after signing the informed consent until the last study visit, whether or not the event is believed to be causally related to study medication (IMP) or comparative compound. This definition includes any worsening of conditions that were present at the time of entry into the study (signing of the informedconsent) (see International Conference on Harmonization (ICH-E2A). AEs occurring after signing the informed consent but before administration of study medication are defined as non-treatment-emergent events. Those events are evaluated separately because in these cases a causal relationship with the study medication can be excluded.
Measured: Day 0 (at start and after treatment),Day 1, Day 7 (at start and after treatment), Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start13 Oct 2014
- Primary completion8 Jun 2015
- Study completion8 Jun 2015
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oystershell NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dörte Wolf, PhD, Principal investigator, CardioSec Clinical Research GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333054
- Sponsor's protocol ID
- NCLIN0091/ 14ct/mp37li
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled, Investigator Blinded, Comparative Study to Evaluate the Safety and Efficacy of a Head Lice Shampoo.
- ClinicalTrials.gov ID
- NCT06333054
- Acronym / sponsor ID
- NCLIN0091/ 14ct/mp37li
- Conditions
- Head Lice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Oystershell NVIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2014 (actual)
- Primary completion
- 8 Jun 2015 (actual)
- Study completion
- 8 Jun 2015 (actual)
- First posted
- 27 Mar 2024 (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 study is designed to compare the effectiveness and safety of test head lice shampoo (Test product) versus Goldgeist® Forte (reference product) following two applications.
Detailed description
The primary objective was to show, that the cure rate after local application of Test head lice shampoo is better than a predefined limit. It had to be shown, that the Test head lice shampoo achieved a cure rate superior to 70% (cure rate at the end of day 10, corrected for re-infestation).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silcap Shampoo | Experimental | Device: Silcap ShampooSubjects with head lice were treated with Silcap Shampoo at visit 1 (day 0) and at visit 3 (day 7). |
| Goldgeist® Forte | Active comparator | Drug: Pyrethrum ExtractSubjects with head lice were treated with Goldgeist® Forte at visit 1 (day 0) and at visit 3 (day 7). |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Gender: male/female
- Age: ≥ 1 year of age at the time of signing the informed consent
- Patients with active head lice infestation of at least 5 living lice and 5 apparently living eggs
- Patient or his/her guardian must be capable of understanding and providing written informed consent
- The patient or his/her legal representative must give written informed consent, after having been oral and written informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the subjects participating in the study
Key exclusion criteria (12 listed)
- Known allergic reactions or hypersensitivity to the active ingredients used or the constituents
- Patients with known skin allergies, multiple drug allergies or multiple allergies to cosmetic products
- Pregnant or breast feeding women
- Patient underwent treatment with any form of head lice treatment within the last 30 days prior to the Screening Visit (day 0)
- Patients with chronic scalp disorder
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 |
|---|---|---|
| Pyrethrum ExtractTreatment with Goldgeist® Forte | Drug | Goldgeist® Forte |
| Silcap ShampooAlso: ParanixTreatment with Silcap Shampoo | Device | Silcap Shampoo |
Primary outcome
Cure Rate superior to 70% for the test product
Time frame: Day 10
The primary objective was to show, that the cure rate after local application of Test head lice shampoo is better than a predefined limit. It had to be shown, that the Test head lice shampoo achieved a cure rate superior to 70% (cure rate at the end of day 10, corrected for re-infestation).
9 secondary outcomes
Cure Rate superior to 70% for the reference product
Time frame: Day 10
Superior cure rate to the reference
Time frame: Day 10
Non-inferiority rate to the reference
Time frame: Day 10
Local tolerability
Time frame: Day 0 (at start and after treatment), Day 1, Day 7 (at start and after treatment), Day 10
Global tolerability
Time frame: Day 10
Skin irritation assessment
Time frame: Day 0 (before, at start and after treatment),Day 1, Day 7 (before, at start and after treatment), Day 10
Eye irritation assessment
Time frame: Day 0 (before, at start and after treatment),Day 1, Day 7 (before, at start and after treatment), Day 10
Esthetical effect of the anti-lice products
Time frame: Day 0 (after treatment); day 7 (after treatment)
Adverse Events (AEs)
Time frame: Day 0 (at start and after treatment),Day 1, Day 7 (at start and after treatment), Day 10
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 27 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
Dörte Wolf, PhD principal investigator
CardioSec Clinical Research GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pyrethrum Extract in people with Head Lice, run by Oystershell NV at 1 site in Germany.
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 10 inclusion and 12 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 27 Mar 2024. 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 Germany. 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.
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?
Cure Rate superior to 70% for the test product (time frame: Day 10). 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 27 Mar 2024.