Trial · NCT02913612
Efficacy, Safety and Pharmacokinetics of Topical Timolol in Infants With Infantile Hemangioma (IH)
NCT02913612, Phase 2, Completed, Kanecia Obie Zimmerman; results first posted 2022-11-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy, Safety and Pharmacokinetics of Topical Timolol in Infants With Infantile Hemangioma (IH). Trials, record NCT02913612. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02913612
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety and Pharmacokinetics of Topical Timolol in Infants With Infantile Hemangioma (IH)
- NCT number
- NCT02913612
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 105 participants, actual
- Lead sponsor
- Kanecia Obie Zimmerman
- Conditions
- Infantile Hemangioma
- Interventions
- 0.25% Timolol Maleate Gel Forming Solution, 0.5% Timolol Maleate Gel Forming Solution
- First posted
- 2016-09-26
- Last updated
- 2024-03-12
- Results first posted
- 2022-11-15
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Partial Response of Hemangioma Volume as Measured by VAS (Visual Analog Scale) Within Each Treatment Arm and Compared With Untreated Controls | 180 days | The VAS-volume is a 100 mm scale used to independently grade hemangioma volume. -100 indicates hemangioma has doubled in size, 0 indicates no change, and +100 indicates complete shrinkage. Partial response is defined as \>20% and up to 80% reduction in volumetric size of hemangioma. |
| Secondary | Number of Participants With Partial Response in Hemangioma Color as Measured by VAS (Visual Analog Scale) Within Each Treatment Arm and Compared With Untreated Controls | 180 days | The VAS-color is a 100 mm scale used to independently grade hemangioma color. -100 indicates hemangioma is twice as intense, 0 indicates no change, and +100 indicates complete resolution. Partial response is defined as \>30% and up to 80% reduction in color of hemangioma. |
| Secondary | Number of Participants With Partial Response of Hemangioma Volume as Measured by VAS (Visual Analog Scale) Within Each Treatment Arm | 180 days | The VAS-volume is a 100 mm scale used to independently grade hemangioma volume. -100 indicates hemangioma has doubled in size, 0 indicates no change, and +100 indicates complete shrinkage. Partial response is defined as \>20% and up to 80% reduction in volumetric size of hemangioma. |
| Secondary | Comparison of Partial Response of Hemangioma Color From Baseline to 180 Days, Within Each Treatment Arm | 180 days | Comparison of partial response of hemangioma color (partial response or greater as assessed by VAS-color) between the two treatment arms. Partial response: \>30% and up to 80% reduction in color of hemangioma. |
| Secondary | Change in Hemangioma Dynamic Complication Scale (HDCS) | baseline, day 180 | Absolute change in hemangioma dynamic complication scale from Day 0 to end of study within each treatment arm. The HDCS provides a 6-point severity grading system for 12 individual hemangioma-related complications (grade 0 represents absent to minimal; grade 5 = most severe). The total score ranges from 0-60. |
| Secondary | Number of Participants Who Reach Partial Response, Assessed by Volume | 30 days, 60 days, 120 days, 180 days | Assess time to partial response or greater by VAS-volume, comparing baseline to day 30, day 60, day 120 and day 180. Partial response: \>20% and up to 80% reduction in volumetric size of hemangioma |
| Secondary | Number of Participants Who Reach Partial Response, Assessed by Hemangioma Color | 180 days | Assess time to partial response or greater by VAS-color, comparing baseline to day 30, day 60, day 120 and day 180. Partial response: \>30% and up to 80% reduction in color of hemangioma |
| Secondary | Change in Hemangioma Quality of Life (IH-QoL) Assessment for Infants | baseline, day 180 | Absolute change in IH-QoL score scale from Day 0 to end of study within each treatment arm. The IH-QoL score scale consists of 4 domains (physical symptom of patient, social functioning of patient, social and psychological functioning of caregiver, and emotional functioning of caregiver) and 29 items, with each item scored on a Likert scale : 0 = never a problem, 1 = almost never a problem, 2 = sometimes a problem, 3 = often a problem and 4 = almost always a problem). The total range is 0-116; the higher the total number indicates a worse outcome. |
| Secondary | Number of Serious Adverse Events and Adverse Events of Special Interest in Infants Treated With Topical Timolol Maleate | up to 270 days | Serious adverse events and adverse events of special interest from randomization to Day 180 in infants treated with topical timolol maleate (0.25% and 0.5%) GFS for the treatment of infantile hemangioma. |
| Other | Pharmacokinetics (PK) Analysis Measuring Maximum Concentration of Timolol in Plasma Specimen | Up to 12 hours | The PK blood samples will be 1.0 ml each and collected between the following timeframes after application of Timolol: within 2 hours, 2-4 hours, 5-7 hours, 8-10 hours or 11-12 hours. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Partial Response of Hemangioma Volume as Measured by VAS (Visual Analog Scale) Within Each Treatment Arm and Compared With Untreated Controls | 180 days | The Historical Control group was included with the Non-intervention group. Excludes 8 participants (four in the 0.5% dosage and four in the historical placebo controls) with out come determined to be unevaluable as they have no reported VAS scores | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Partial Response in Hemangioma Color as Measured by VAS (Visual Analog Scale) Within Each Treatment Arm and Compared With Untreated Controls | 180 days | The Historical Control group was included with the Non-intervention group. Only participants with evaluable data were included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Partial Response of Hemangioma Volume as Measured by VAS (Visual Analog Scale) Within Each Treatment Arm | 180 days | Only participants with evaluable data were included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Comparison of Partial Response of Hemangioma Color From Baseline to 180 Days, Within Each Treatment Arm | 180 days | Only participants with evaluable data were included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Hemangioma Dynamic Complication Scale (HDCS) | baseline, day 180 | Only participants with evaluable data were included in the analysis. | score on a scale | MEAN |
| SECONDARY | Number of Participants Who Reach Partial Response, Assessed by Volume | 30 days, 60 days, 120 days, 180 days | Only participants with evaluable data were included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Reach Partial Response, Assessed by Hemangioma Color | 180 days | Only participants with evaluable data were included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Hemangioma Quality of Life (IH-QoL) Assessment for Infants | baseline, day 180 | Only participants with evaluable data were included in the analysis. | score on a scale | MEAN |
| SECONDARY | Number of Serious Adverse Events and Adverse Events of Special Interest in Infants Treated With Topical Timolol Maleate | up to 270 days | Only participants who received treatment and had evaluable data were included in this analysis | adverse events | NUMBER |
| OTHER_PRE_SPECIFIED | Pharmacokinetics (PK) Analysis Measuring Maximum Concentration of Timolol in Plasma Specimen | Up to 12 hours |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Partial Response of Hemangioma Volume as Measured by VAS (Visual Analog Scale) Within Each Treatment Arm and Compared With Untreated Controls | 0.25% Timolol Treatment | 24 | Participants | ||
| Number of Participants With Partial Response of Hemangioma Volume as Measured by VAS (Visual Analog Scale) Within Each Treatment Arm and Compared With Untreated Controls | 0.5% Timolol Treatment | 28 | Participants | ||
| Number of Participants With Partial Response of Hemangioma Volume as Measured by VAS (Visual Analog Scale) Within Each Treatment Arm and Compared With Untreated Controls | Non-Intervention Group | 15 | Participants | ||
| Number of Participants With Partial Response in Hemangioma Color as Measured by VAS (Visual Analog Scale) Within Each Treatment Arm and Compared With Untreated Controls | 0.25% Timolol Treatment | 32 | Participants | ||
| Number of Participants With Partial Response in Hemangioma Color as Measured by VAS (Visual Analog Scale) Within Each Treatment Arm and Compared With Untreated Controls | 0.5% Timolol Treatment | 34 | Participants | ||
| Number of Participants With Partial Response in Hemangioma Color as Measured by VAS (Visual Analog Scale) Within Each Treatment Arm and Compared With Untreated Controls | Non-Intervention Group | 19 | Participants | ||
| Number of Participants With Partial Response of Hemangioma Volume as Measured by VAS (Visual Analog Scale) Within Each Treatment Arm | 0.25% Timolol Treatment | 24 | Participants | ||
| Number of Participants With Partial Response of Hemangioma Volume as Measured by VAS (Visual Analog Scale) Within Each Treatment Arm | 0.5% Timolol Treatment | 28 | Participants | ||
| Comparison of Partial Response of Hemangioma Color From Baseline to 180 Days, Within Each Treatment Arm | 0.25% Timolol Treatment | 32 | Participants | ||
| Comparison of Partial Response of Hemangioma Color From Baseline to 180 Days, Within Each Treatment Arm | 0.5% Timolol Treatment | 34 | Participants |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 0.25% Timolol Treatment | 44 | |
| Overall Study | STARTED | 0.5% Timolol Treatment | 51 | |
| Overall Study | STARTED | Non-Intervention Group | 10 | |
| Overall Study | STARTED | Historical Controls | 36 | |
| Overall Study | COMPLETED | 0.25% Timolol Treatment | 32 | |
| Overall Study | COMPLETED | 0.5% Timolol Treatment | 33 | |
| Overall Study | COMPLETED | Non-Intervention Group | 7 | |
| Overall Study | COMPLETED | Historical Controls | 36 | |
| Overall Study | NOT COMPLETED | 0.25% Timolol Treatment | 12 | |
| Overall Study | NOT COMPLETED | 0.5% Timolol Treatment | 18 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events256
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 | Dacryostenosis congenital | Congenital, familial and genetic disorders | 0.25% Timolol Treatment | 1 | 44 | |
| other | Dacryostenosis congenital | Congenital, familial and genetic disorders | 0.5% Timolol Treatment | 0 | 51 | |
| other | Dacryostenosis congenital | Congenital, familial and genetic disorders | Non-Intervention Group | 0 | 10 | |
| other | Dacryostenosis congenital | Congenital, familial and genetic disorders | Historical Controls | 0 | ||
| other | Plagiocephaly | Congenital, familial and genetic disorders | 0.25% Timolol Treatment | 0 | 44 | |
| other | Plagiocephaly | Congenital, familial and genetic disorders | 0.5% Timolol Treatment | 1 | 51 | |
| other | Plagiocephaly | Congenital, familial and genetic disorders | Non-Intervention Group | 0 | 10 | |
| other | Plagiocephaly | Congenital, familial and genetic disorders | Historical Controls | 0 | ||
| other | Amblyopia | Eye disorders | 0.25% Timolol Treatment | 1 | 44 | |
| other | Amblyopia | Eye disorders | 0.5% Timolol Treatment | 0 | 51 |
1 to 10 of 256Source ClinicalTrials.gov
See all 256 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 0.25% Timolol Treatment | 0 | 44 |
| Total, all-cause mortality | 0.5% Timolol Treatment | 0 | 51 |
| Total, all-cause mortality | Non-Intervention Group | 0 | 10 |
| Total, all-cause mortality | Historical Controls | 0 | 0 |
| Total, other adverse events | 0.25% Timolol Treatment | 31 | 44 |
| Total, other adverse events | 0.5% Timolol Treatment | 28 | 51 |
| Total, other adverse events | Non-Intervention Group | 4 | 10 |
| Total, other adverse events | Historical Controls | 0 | 0 |
| Total, serious adverse events | 0.25% Timolol Treatment | 3 | 44 |
| Total, serious adverse events | 0.5% Timolol Treatment | 2 | 51 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30790601 | BACKGROUND |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 0.25% Timolol Treatment vs 0.5% Timolol Treatment: Number of Participants With Partial Response of Hemangioma Volume as Measured by VAS (Visual Analog Scale) Within Each Treatment Arm | Trial comparisons |
| 0.25% Timolol Treatment vs 0.5% Timolol Treatment: Comparison of Partial Response of Hemangioma Color From Baseline to 180 Days, Within Each Treatment Arm | Trial comparisons |
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/NCT02913612
GET https://conductscience.org/api/trials/v1/NCT02913612/results?page=2