A Phase 3 interventional study of Spinosad and Spinosad in Pediculosis, sponsored by ParaPRO LLC. Completed at 6 sites in United States. Open to participants aged 6 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-10-11.
Sponsored by ParaPRO LLC · Phase 3, Interventional, and Treatment
A comparative safety and efficacy study of NatrOVA Creme Rinse - 1% versus NIX Creme Rinse, under actual use conditions in subjects 6 months of age or greater who are infested with Pediculosis capitis (human head lice).
This is a Phase 3 multi-site, randomized, evaluator/investigator-blinded, three-arm, parallel group study evaluating the safety and efficacy of NatrOVA Creme Rinse - 1% (with nit combing and without nit combing) versus NIX Creme Rinse in an "actual use" environment.
43 studies on the registry are indexed under Lice Infestations; 4 are open to participants now.
This study's enrollment of 558 is above the median of 105 across 42 interventional studies indexed under Lice Infestations.
Browse Lice Infestations studies →ParaPRO LLC is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NatrOVA Creme Rinse (spinosad) 1% - no nit combing required
Drug: Spinosad
NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required
Drug: Spinosad
NIX Creme Rinse (permethrin 1%) applied to Over the Counter (OTC) Instructions for Use
Drug: Permethrin 1%
10 minute topical application product, following by a complete rinse off.
Also known as: Natroba (spinosad) Topical Suspension, 0.9%
10 minute topical application followed by a complete rinse off, followed by a nit combing regimen
Also known as: Natroba (spinosad) Topical Suspension, 0.9%
Topical application for 10 minutes, followed by a complete rinse off, followed by a nit combing regimen
Also known as: NIX Creme Rinse
Efficacy of NatrOVA Creme Rinse - 1% Relative to NIX Creme Rinse in Subjects Infested With Head Lice
The primary efficacy endpoint was the proportion of primary subjects in the enrolled households who were lice free (no live lice, adults or nymphs), as assessed by the trained evaluator, 14 days after the last treatment (i.e., Day 14 for subjects who treated once and Day 21 for subjects who treated twice).
Time frame: Assessment were made 14 days following the final product treatment
Evaluation of the Safety of NatrOVA Creme Rinse - 1% Based Upon Reported Adverse Events and Observed Skin/Scalp Reactions.
To evaluate the safety of NatrOVA® 1% Creme Rinse based upon reported adverse events and observed skin/scalp reactions. Additional safety assessments included cutaneous/ocular irritation.
Time frame: Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments)
The first subject signed an informed consent and enrolled into the study on 25 September 2007; the last follow-up visit occurred on 22 April 2008.
| Milestone | A - NatrOVA 1% - No Nit Combing Required | B - NatrOVA 1% - Nit Combing Required | C - NIX Applied Per Over the Counter (OTC) Instructions |
|---|---|---|---|
| Started | 243 | 59 | 256 |
| Completed | 227 | 54 | 230 |
| Not completed | 16 | 5 | 26 |
| Withdrew: Withdrawal by subject | 0 | 1 | 10 |
| Withdrew: Lost to follow-up | 13 | 3 | 12 |
| Withdrew: Protocol violation | 3 | 1 | 4 |
The primary efficacy endpoint was the proportion of primary subjects in the enrolled households who were lice free (no live lice, adults or nymphs), as assessed by the trained evaluator, 14 days after the last treatment (i.e., Day 14 for subjects who treated once and Day 21 for subjects who treated twice).
| participants | A - NatrOVA 1% - No Nit Combing Required | B - NatrOVA 1% - Nit Combing Required | C - NIX Applied Per Over the Counter (OTC) Instructions |
|---|---|---|---|
| Success (no live lice present) | 77 | 19 | 40 (32.7% to 57.5%) |
| Failure (live lice present) | 14 | 4 | 49 |
To evaluate the safety of NatrOVA® 1% Creme Rinse based upon reported adverse events and observed skin/scalp reactions. Additional safety assessments included cutaneous/ocular irritation.
| Incidents | A/B - NatrOVA 1% - With/Without Nit Combing | C - NIX Applied Per Over the Counter (OTC) Instructions |
|---|---|---|
| Ear and labyrinth disorders - Ear pain | 0 | 1 |
| Eye disorders - Eye irritation | 0 | 3 |
| Eye disorders - pruritus | 0 | 1 |
| Eye disorders - Lacrimination increased | 0 | 1 |
| Eye disorders - Occular hyperaemia | 12 | 15 |
| Gastrointestinal disorders - Diarrhea | 1 | 0 |
| Gastrointestinal disorders - Stomach discomfort | 1 | 0 |
| Gastrointestinal disorders - Vomiting | 1 | 0 |
| Administration site conditions - discoloration | 0 | 1 |
| Administration site conditions - Dryness | 1 | 0 |
| Administration site conditions - Erythema | 15 | 17 |
| Administration site conditions - Irritation | 5 | 6 |
| Administration site conditions - Scab | 0 | 1 |
| General Disorder - Pyrexia | 1 | 1 |
| Infections and infestations - Cellulitis | 0 | 1 |
| Infections and infestations - Influenza | 1 | 0 |
| Infections and infestations - Nasopharyngitis | 1 | 2 |
| Infections and infestations - Otitis media | 1 | 0 |
| Infections - Pharyngitis streptococal | 0 | 1 |
| Infections - Upper respiratory tract infection | 0 | 3 |
| Injury - Skin laceration | 1 | 0 |
| Nervous system disorders - Headache | 1 | 1 |
| Nervous system disorders - Syncope | 0 | 1 |
| Respiratory -Chronic obstructive pulmonary disease | 0 | 1 |
| Respiratory - Cough | 1 | 1 |
| Respiratory disorders - pharyngolaryngeal pain | 1 | 0 |
| Skin disorders - Alopecia | 1 | 0 |
| Skin disorders - Dry skin | 1 | 1 |
| Skin disorders - Erythema | 1 | 4 |
Collected over Through out the study (7 months).. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| A/B - NatrOVA 1% - With/Without Nit Combing | — | 0/294 (0%) | 34/294 (11.6%) |
| C - NIX Applied Per Over the Counter (OTC) Instructions | — | 2/246 (0.8%) | 49/246 (19.9%) |
| Event | A/B - NatrOVA 1% - With/Without Nit Combing | C - NIX Applied Per Over the Counter (OTC) Instructions |
|---|---|---|
| Application Site ErythemaGeneral disorders | 0/294 | 1/246 |
| CellulitisInfections and infestations | 0/294 | 1/246 |
| Event | A/B - NatrOVA 1% - With/Without Nit Combing | C - NIX Applied Per Over the Counter (OTC) Instructions |
|---|---|---|
| Application site erythemaGeneral disorders | 15/294 | 16/246 |
| Occular hyperaemiaEye disorders | 12/294 | 15/246 |
| Application site irritationGeneral disorders | 5/294 | 6/246 |
| ErythemaSkin and subcutaneous tissue disorders | 1/294 | 4/246 |
| Eye irritationEye disorders | 0/294 | 3/246 |
| Upper respiratory tract infectionInfections and infestations | 0/294 | 3/246 |
| NasopharyngitisInfections and infestations | 1/294 | 2/246 |
| Age, Categorical(Participants) | A - NatrOVA 1% - No Nit Combing Required | B - NatrOVA 1% - Nit Combing Required | C - NIX Applied Per Over the Counter (OTC) Instructions | Total |
|---|---|---|---|---|
| <=18 years | 172 | 40 | 177 | 389 |
| Between 18 and 65 years | 70 | 19 | 78 | 167 |
| >=65 years | 1 | 0 | 1 | 2 |
| Age Continuous(years) | A - NatrOVA 1% - No Nit Combing Required | B - NatrOVA 1% - Nit Combing Required | C - NIX Applied Per Over the Counter (OTC) Instructions | Total |
|---|---|---|---|---|
| Mean | 16 ± 15 | 19 ± 16 | 17 ± 14 | 17 ± 15 |
| Sex: Female, Male(Participants) | A - NatrOVA 1% - No Nit Combing Required | B - NatrOVA 1% - Nit Combing Required | C - NIX Applied Per Over the Counter (OTC) Instructions | Total |
|---|---|---|---|---|
| Female | 200 | 47 | 210 | 457 |
| Male | 43 | 12 | 46 | 101 |
| Region of Enrollment(participants) | A - NatrOVA 1% - No Nit Combing Required | B - NatrOVA 1% - Nit Combing Required | C - NIX Applied Per Over the Counter (OTC) Instructions | Total |
|---|---|---|---|---|
| United States | 243 | 59 | 256 | 558 |
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Spinosad
ParaPRO LLC