Trial · NCT01907490
Safety and PK Study of Ha44 Gel Under Maximal Use Conditions for Treatment of Head Lice Infestation
NCT01907490, Phase 2, Completed, Dr. Reddy's Laboratories Limited, India; results first posted 2015-02-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and PK Study of Ha44 Gel Under Maximal Use Conditions for Treatment of Head Lice Infestation. Trials, record NCT01907490. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01907490
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and PK Study of Ha44 Gel Under Maximal Use Conditions for Treatment of Head Lice Infestation
- NCT number
- NCT01907490
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 38 participants, actual
- Lead sponsor
- Dr. Reddy's Laboratories Limited, India
- Conditions
- Head Lice Infestation
- Interventions
- Ha44 Gel
- First posted
- 2013-07-25
- Last updated
- 2020-04-28
- Results first posted
- 2015-02-09
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of the Subjects With AEs. | 3 months | Safety and tolerability assessed by AEs. Number of subjects with reporting AEs. |
| Secondary | Pk Parameters: Cmax | 0 to 8 hours | Maximum concentration of Ha44 (Cmax) |
| Secondary | PK Parameters: Tmax | 0-8 hours | Time to maximum concentration of Ha44 (Tmax) |
| Secondary | PK Parameters: AUC(0-8) | 0-8 hours | Area under the concentration-time curve of Ha44 (AUC 0-8) |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of the Subjects With AEs. | 3 months | paediatric population, children between ages 6 months to \<18 years. | participants | NUMBER |
| SECONDARY | Pk Parameters: Cmax | 0 to 8 hours | Pharmacokinetic (PK) population included subjects who had sufficient concentration-time profiles for PK analyses. | ng/mL | MEAN |
| SECONDARY | PK Parameters: Tmax | 0-8 hours | PK population | hours | MEDIAN |
| SECONDARY | PK Parameters: AUC(0-8) | 0-8 hours | PK Population | ng.h/mL | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of the Subjects With AEs. | Ha44 Gel 0.74% w/w | 8 | participants | ||
| Pk Parameters: Cmax | HA44 Gel 0.74% | 141.4 | Full Range 16 to 397 | ng/mL | |
| PK Parameters: Tmax | HA44 Gel 0.74% | 0.8 | Full Range 0 to 2 | hours | |
| PK Parameters: AUC(0-8) | HA44 Gel 0.74% | 447.5 | Full Range 80 to 971 | ng.h/mL |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ha44 Gel 0.74% w/w | 38 | |
| Overall Study | COMPLETED | Ha44 Gel 0.74% w/w | 38 | |
| Overall Study | NOT COMPLETED | Ha44 Gel 0.74% w/w | 0 |
Source ClinicalTrials.gov
Adverse events1
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dermatitis contact | Skin and subcutaneous tissue disorders | Ha44 Gel 0.74% w/w | 2 | 38 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ha44 Gel 0.74% w/w | 0 | 38 |
| Total, other adverse events | Ha44 Gel 0.74% w/w | 2 | 38 |
| Total, serious adverse events | Ha44 Gel 0.74% w/w | 0 | 38 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01907490
GET https://conductscience.org/api/trials/v1/NCT01907490/registered