Trial · NCT06677853
Timolol Maleate Gel for the Treatment of Infantile Hemangioma
NCT06677853, Phase 2, Phase 3, Completed, Auson Pharmaceuticals Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Timolol Maleate Gel for the Treatment of Infantile Hemangioma. Trials, record NCT06677853. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06677853
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Timolol Maleate Gel for the Treatment of Infantile Hemangioma
- NCT number
- NCT06677853
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 168 participants, actual
- Lead sponsor
- Auson Pharmaceuticals Inc.
- Conditions
- Infantile Hemangioma
- Interventions
- Timolol Maleate Gel+Placebo, Timolol Maleate Gel, Placebo
- First posted
- 2024-11-07
- Last updated
- 2024-11-07
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Success rate of cure of IH after 24-week treatment. | 24 weeks | Treatment success is defined as complete or almost complete resolution of the patient's IH at W24 compared with baseline. At the time of centralized independent assessment. |
| Secondary | Changes in the hemangioma volume | baseline, week 4, 12 and 24 | Changes in the hemangioma volume from baseline after treatment for 4, 12 and 24 weeks, adopting the estimation formula of IH volume: V = 0.07×(the average of the hemangioma's longest length and width)\^3. |
| Secondary | Changes in hemangioma color | baseline, weeks 4, 12 and 24 | Change in the color of hemangioma after 4, 12, and 24 weeks of treatment, which is assessed by the CEA (Clinician Erythema Assessment) criteria.The color intensity (e.g., no signs of erythema;slight redness;defined redness;marked redness;fiery redness.) of the IH is assessed on a 5 point scale. |
| Secondary | Complete/almost complete regression rates of IH from baseline after 4 and 12-week treatment. | baseline, weeks 4 and 12 | At the time of centralized independent assessment. |
| Secondary | Complete/almost complete resolution rate of IH at each post-baseline visit (Weeks 4, 12, and 24) from baseline. | baseline, Weeks 4, 12, and 24 | On-site qualitative assessment by the investigator of efficacy. |
| Secondary | Evolution of IH at each post-baseline visit(Weeks 4, 12, and 24) from baseline. | baseline, Weeks 4, 12 and 24 | Classified into 5 categories: completely/almost completely resolved, improved, stable, aggravated, and not assessable. On-site qualitative assessment by the investigator of efficacy. |
| Secondary | Changes in IH at each post-baseline visit(Weeks 4, 12, and 24) compared to the previous visit. | Baseline, Weeks 4, 12, and 24 | Classified into 5 categories: complete/almost complete regression, relief, stabilization, exacerbation, and unable to determine. On-site qualitative assessment by the investigator of efficacy. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT06677853
GET https://conductscience.org/api/trials/v1/NCT06677853/registered