NCT03617926 is a NA clinical trial of X92001666 in Head Lice, sponsored by Oystershell NV.

Who is sponsoring NCT03617926?

NCT03617926 is sponsored by Oystershell NV.

What drugs are being tested in NCT03617926?

Interventions in NCT03617926: X92001666, RID shampoo.

What condition does NCT03617926 study?

NCT03617926 studies Head Lice, Pediculosis Capitis.

Is NCT03617926 still recruiting?

NCT03617926 is currently completed. Last updated 5 July 2022.

Are results published for NCT03617926?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-07-05 · How we verify

NCT03617926

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Clinical Trial to Evaluate Efficacy and Safety of a Water-soluble Head Lice Product.

Completed NA Results posted Last updated 5 July 2022

What this trial tests

NA trial testing X92001666 in Head Lice in 70 participants. Completed in 30 June 2018.

Timeline

7 March 2018

Primary endpoint
30 June 2018

30 June 2018

Quick facts

Lead sponsor	Oystershell NV
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	70
Start date	7 March 2018
Primary completion	30 June 2018
Estimated completion	30 June 2018
Sites	2 locations across United States

Drugs / interventions tested

X92001666
RID shampoo

Conditions studied

Head Lice — all drugs for Head Lice →
Pediculosis Capitis — all drugs for Pediculosis Capitis →

Sponsor

Oystershell NV — full company profile →

Who can join

2 and older, any sex, with Head Lice or Pediculosis Capitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Subjects That Are Lice-free After 2 Treatments With Test Product (Including All Baseline Infestations). Primary · Day10

Clinical efficacy is reflected by the % of subjects that are lice-free after 2 topical applications (at day 0 \& day 7 respectively) of the test product. In this analysis, all baseline infestations (mild, moderate, severe) have been included. Assessment is performed at study end (visit 4, day 10). A mild infestation corresponds to 5-9 lice and/or nymphs A moderate infestation corresponds to 10-24 lice and/or nymphs A severe infestation corresponds to 25 or more lice and/or nymphs

Number of lice-free subjects (uncorrected for re-infestation)

Group	Value	95% CI
Test Product	30

Number of lice-free subjects (corrected for re-infestation)

Group	Value	95% CI
Test Product	30

Number of Subjects That Are Lice-free After 2 Treatments With Reference Product (Including All Baseline Infestations). Secondary · Day 10

Clinical efficacy is reflected by the % of subjects that are lice-free after 2 topical applications (at day 0 \& day 7 respectively) of the reference product. In this analysis, all baseline infestations (mild, moderate, severe) have been included. Assessment is performed at study end (visit 4, day 10). A mild infestation corresponds to 5-9 lice and/or nymphs A moderate infestation corresponds to 10-24 lice and/or nymphs A severe infestation corresponds to 25 or more lice and/or nymphs

Number of lice-free subjects (uncorrected for re-infestation)

Group	Value	95% CI
Reference Product	13

Number of lice-free subjects (corrected for re-infestation)

Group	Value	95% CI
Reference Product	13

Number of Subjects That Are Lice-free After 2 Treatments With Test Product (Only Mild and Moderate Baseline Infestations). Secondary · Day 10

The % of subjects with a mild (5-9 lice and/or nymphs) and moderate (10-24 lice and/or nymphs) baseline infestation that are lice-free after two topical treatments (day 0 \& day 7) with the test product; assessed at study end (visit 4; day 10).

Group	Value	95% CI
Test Product	25

Number of Subjects That Are Lice-free After 2 Treatments With Reference Product (Only Mild and Moderate Baseline Infestations). Secondary · Day 10

The % of subjects with a mild (5-9 lice and/or nymphs) and moderate (10-24 lice and/or nymphs) baseline infestation that are lice-free after two topical treatments (day 0 \& day 7) with the reference product; assessed at study end (visit 4; day 10).

Group	Value	95% CI
Reference	13

Number of Subjects That Are Lice-Free After 1 Treatment With Test Product (All Baseline Infestations). Secondary · Day 1

The % of subjects that are lice-free after one topical treatment with the test product (assessment 24h post treatment), considering all baseline infestations (mild, moderate, severe). A mild infestation corresponds to 5-9 lice and/or nymphs A moderate infestation corresponds to 10-24 lice and/or nymphs A severe infestation corresponds to 25 or more lice and/or nymphs

Group	Value	95% CI
Test Product	30

Number of Subjects That Are Lice-free After 1 Treatment With Reference Product (All Baseline Infestations). Secondary · Day 1

The % of subjects that are lice-free after one topical treatment with the reference product (assessment 24h post treatment), considering all baseline infestations (mild, moderate, severe). A mild infestation corresponds to 5-9 lice and/or nymphs A moderate infestation corresponds to 10-24 lice and/or nymphs A severe infestation corresponds to 25 or more lice and/or nymphs

Group	Value	95% CI
Reference	21

Effect of Both Investigational Treatments on Pruritus (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator. Secondary · Day 0, Day 1, Day 7, Day10

The occurrence and degree of pruritus is rated by the blinded clinical investigator at each visit, using the following scores: none (best outcome), mild, moderate, and severe (worst outcome). None: the scalp does not itch; Mild: occasional episodes of itching, not bothersome; Moderate: frequent, several times a day, bothersome; Severe: nearly constant, frequent scratching, very bothersome.

Pruritus D0 pre-treatment

Group	Value	95% CI
Test Product	27
Reference	24

Pruritus D0 post-treatment

Group	Value	95% CI
Test Product	14
Reference	13

Pruritus D1

Group	Value	95% CI
Test Product	8
Reference	5

Pruritus D7 pre-treatment

Group	Value	95% CI
Test Product	9
Reference	8

Pruritus D7 post-treatment

Group	Value	95% CI
Test Product	4
Reference	3

Pruritus D10

Group	Value	95% CI
Test Product	7
Reference	5

Effect of Both Investigational Treatments on Scalp Excoriation (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator. Secondary · Day 0, Day 1, Day 7, Day10

The occurrence and degree of scalp excoriation (breaking of the skin, usually caused by scratching) is rated by the blinded clinical investigator at each visit, using the following scores: none (best outcome), mild, moderate, and severe (worst outcome). None: no broken skin on the scalp; Mild: one or two areas on the scalp on which skin is broken; Moderate: more than two separate areas of the scalp with broken skin but not generalized across the scalp; Severe: widespread breaking of the skin involving most of the scalp.

Scalp Excoriation D0 pre-treatment

Group	Value	95% CI
Test Product	0
Reference	0

Scalp Excoriation D0 post-treatment

Group	Value	95% CI
Test Product	0
Reference	0

Scalp Excoriation D1

Group	Value	95% CI
Test Product	0
Reference	0

Scalp Excoriation D7 pre-treatment

Group	Value	95% CI
Test Product	0
Reference	0

Scalp Excoriation D7 post-treatment

Group	Value	95% CI
Test Product	0
Reference	0

Scalp Excoriation D10

Group	Value	95% CI
Test Product	0
Reference	0

Effect of Both Investigational Treatments on Paraesthesia (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator. Secondary · Day 0, Day 1, Day 7, Day10

The occurrence and degree of paraesthesia (tingling or prickling sensation) is rated by the blinded clinical investigator at each visit, using the following scores: none (best outcome), mild, moderate, and severe (worst outcome). None: no tingling or prickling sensation; Mild: occasional tingling or prickling sensation; Moderate: frequent tingling or prickling sensation; Severe: nearly constant tingling or prickling sensation

Paraesthesia D0 pre-treatment

Group	Value	95% CI
Test Product	0
Reference	0

Paraesthesia D0 post-treatment

Group	Value	95% CI
Test Product	0
Reference	0

Paraesthesia D1

Group	Value	95% CI
Test Product	0
Reference	0

Paraesthesia D7 pre-treatment

Group	Value	95% CI
Test Product	0
Reference	0

Paraesthesia D7 post-treatment

Group	Value	95% CI
Test Product	0
Reference	0

Paraesthesia D10

Group	Value	95% CI
Test Product	0
Reference	0

Effect of Both Investigational Treatments on Skin Erythema (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator. Secondary · Day 0, Day 1, Day 7, Day10

The occurrence and degree of skin erythema (redness of the scalp) is rated by the blinded clinical investigator at each visit, using the following scores: none (best outcome), mild, moderate, and severe (worst outcome). None: no redness of the scalp; Mild: faint, barely perceptible erythema with limited distribution; Moderate: diffuse pink areas of scalp are readily visible; Severe: large areas of the scalp are red.

Skin erythema D0 pre-treatment

Group	Value	95% CI
Test Product	0
Reference	1

Skin erythema D0 post-treatment

Group	Value	95% CI
Test Product	0
Reference	1

Skin erythema D1

Group	Value	95% CI
Test Product	0
Reference	1

Skin erythema D7 pre-treatment

Group	Value	95% CI
Test Product	0
Reference	0

Skin erythema D7 post-treatment

Group	Value	95% CI
Test Product	0
Reference	0

Skin erythema D10

Group	Value	95% CI
Test Product	0
Reference	0

Effect of Both Investigational Treatments on Pyroderma (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator. Secondary · Day 0, Day 1, Day 7, Day10

The occurrence and degree of pyroderma (sores filled with clear fluid, pus or crusting) is rated by the blinded clinical investigator at each visit, using the following scores: none (best outcome), mild, moderate, and severe (worst outcome). None: no lesions visible on the scalp; Mild: one or two lesions visible with crusting or other evidence of infection; Moderate: presence of more than two lesions with crusting or other evidence of infection, but not generalized across the scalp; Severe: lesions with crusting or other evidence of infection, involving most of the scalp.

Pyroderma D0 pre-treatment

Group	Value	95% CI
Test Product	0
Reference	1

Pyroderma D0 post-treatment

Group	Value	95% CI
Test Product	0
Reference	0

Pyroderma D1

Group	Value	95% CI
Test Product	0
Reference	0

Pyroderma D7 pre-treatment

Group	Value	95% CI
Test Product	0
Reference	0

Pyroderma D7 post-treatment

Group	Value	95% CI
Test Product	0
Reference	0

Pyroderma D10

Group	Value	95% CI
Test Product	0
Reference	0

Effect of Both Investigational Treatments on Eye Irritation, as Assessed by a Blinded Clinical Investigator. Secondary · Day 0, Day 1, Day 7, Day10

The occurrence and degree of eye irritation (stinging, burning sensation, and/or pain) is rated by the blinded clinical investigator at each visit, using the following scores: none (best outcome), mild, moderate, and severe (worst outcome). None: no stinging, burning or pain Mild: slight mild stinging, burning or pain Moderate: moderate stinging, burning or pain Severe: severe stinging, burning or pain

Eye irritation D0 pre-treatment

Group	Value	95% CI
Test Product	0
Reference	0

Eye irritation D0 post-treatment

Group	Value	95% CI
Test Product	0
Reference	0

Eye irritation D1

Group	Value	95% CI
Test Product	0
Reference	0

Eye irritation D7 pre-treatment

Group	Value	95% CI
Test Product	0
Reference	0

Eye irritation D7 post-treatment

Group	Value	95% CI
Test Product	0
Reference	0

Eye irritation D10

Group	Value	95% CI
Test Product	0
Reference	0

Sponsor's own description

The present study is set-up to compare in vivo clinical performance and safety of the test product versus an in the US commercially available, pyrethrum-based product (RID® shampoo).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Efficacy and Safety of a Water-Based Head Lice Lotion: A Randomized, Controlled, Investigator-Blinded, Comparative, Bicentric Study.
Eertmans F, Rossel B, Serrano L, Rivera E, et al · · 2019 · cited 4× · PMID 30506361 · DOI 10.1007/s13555-018-0274-x

Verify or expand the search:

Other recruiting trials for Head Lice

Currently open trials in the same condition.

NCT07191457 — Safety and Efficacy of Head-lice Treatments Elimax Green Lotion and Walgreens Lice Killing Shampoo · NA · recruiting

Other Oystershell NV trials

Trials by the same sponsor.

NCT07191457 — Safety and Efficacy of Head-lice Treatments Elimax Green Lotion and Walgreens Lice Killing Shampoo · NA · recruiting
NCT05378477 — A Clinical Trial to Evaluate Efficacy and Safety of a New Suffocating Head Lice Product. · NA · unknown
NCT04961684 — Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis · NA · completed
NCT06309446 — Assessment of Wound Healing, Cooling Efficacy and Local Tolerability of a Wound Care Hydrogel · NA · completed
NCT06309420 — Clinical Trial to Evaluate Efficacy and Safety of a Cryogenic Medical Device for Treatment of Common and Plantar Warts · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03617926 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Oystershell NV
Last refreshed: 5 July 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03617926.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing