Trial · NCT02342275
Efficacy and Safety of Propranolol Versus Atenolol on the Proliferative Phase of Infantile Hemangioma
NCT02342275, Phase 3, Completed, West China Hospital; results first posted 2022-06-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Propranolol Versus Atenolol on the Proliferative Phase of Infantile Hemangioma. Trials, record NCT02342275. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02342275
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Propranolol Versus Atenolol on the Proliferative Phase of Infantile Hemangioma
- NCT number
- NCT02342275
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 377 participants, actual
- Lead sponsor
- West China Hospital
- Conditions
- Hemangioma
- Interventions
- Propranolol, Atenolol
- First posted
- 2015-01-19
- Last updated
- 2022-06-16
- Results first posted
- 2022-06-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Primary Outcome Measure Was Any Response at 6 Months | 6 month | Changes in IH size and color were classified as a complete response, nearly complete response, partial response or no response. The primary outcome measure was any response at 6 months in the intention-to-treat population of all patients who underwent randomization. The any response included compete, nearly complete and partial responses. A complete response was defined as no redundant tissue or telangiectasia was identified. A nearly complete response was defined as a minimal degree of telangiectasis, erythema and skin thickening. A partial response was defined as a size reduction or change in color that did not meet the nearly complete resolution criteria. |
| Secondary | Hemangioma Activity Score (HAS) | Baseline and at 1, 4, 12, and 24 weeks | HAS was measured at baseline and at 1, 4, 12, and 24 weeks, including the degree of deep swelling, the color of the hemangioma, and the ulceration assessment: 1. Assessment of the degree of swelling. It was scored as follows: * 6 points if the swelling was tense; * 4 points if the swelling was'neutral; * 2 points when the swelling was reduced by 50% or more at follow-up; or * 0 point when there was no more visible swelling at a follow-up. 2. Assessment of the color of the IH. * 5 points if the hemangioma lesion was bright red all over; * 3 points if the hemangioma lesion was matte red or reddish-purple; * 1 point if the hemangioma lesion was totally or partially gray; * 0 points if the hemangioma lesion was totally or partially skin-colored after involution. (2) Assessment of the ulceration. -0.5 point for an ulcer ≤1.0 cm2; * One point for an ulcer \>1.0 cm2 but \<25 cm2; * Two points for an ulcer ≥25 cm2. The HAS score= (Swelling score + color score)/2 +Ulceration score. |
| Secondary | Successful Initial Response | 1 week after treatment | A successful initial response was defined as a HAS score decrease at 1 week after treatment. A successful initial response was assessed by using HAS in the intention-to-treat population. Previous studies demonstrated that HAS decreases over time after β-blocker treatment, with a dramatic drop occurring in the first week, indicating an immediate therapeutic response. HAS can reflect the rapid effect of β-blocker (either propranolol or atenolol) therapy shortly after initiation. |
| Secondary | Complete Ulceration Healing Time | from the first dosage of propranolol or atenolol until complete healing ofthe hemangioma ulceration. | The complete healing time of the ulceration was defined as the time from the first dosage of propranolol or atenolol until complete healing of the hemangioma ulceration (assessed up to 6 months). Ulceration is defined as a break in the integrity of the hemangioma surface epithelium (or skin) with or without infection. The information included the extent of ulceration, complications of ulceration, prior duration of ulceration (before treatment), concurrent treatments, and complete healing time. Prior duration of ulceration was defined as the time from the first sign of ulceration until before β-blocker treatment. The complete healing time of the ulceration was defined as the time from the first dosage of propranolol or atenolol until complete healing of the hemangioma ulceration. Concurrent treatments, including oral pain medication, oral antibiotics, topical ointment antibiotics and/or wound dressings, were permitted to treat ulcerated IH and were recorded. |
| Secondary | Rebound Rate | between weeks 24 and 96 | Regrowth of more than 20% in hemangioma appearance (including changes in color and/or volume) after stopping the medication was considered significant rebound. The inclusion criteria for rebound analysis were as follows: (1) patients who completed 6 months of treatment and (2) patients who discontinued therapy or were tapering treatment after achieving an any response. The exclusion criteria were as follows: (1) patients who were noncompliant with treatment and (2) patients who did not respond to treatment. Whether a patient had hemangioma rebound was based on the site investigators' assessments after the week 24 treatment. In patients with significant rebound, reinitiation of systemic therapy (either propranolol or atenolol) was recommended. Minor rebound, which was defined as those patients in whose rebound was noted but no reinitiation of systemic therapy or further treatment was necessary, was not included in the analysis. |
| Secondary | Number of Participants With Complete/Nearly Complete Response (96 Week) | 96 week | A complete/nearly complete response at week 96 was considered median-term efficacy. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Primary Outcome Measure Was Any Response at 6 Months | 6 month | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Hemangioma Activity Score (HAS) | Baseline and at 1, 4, 12, and 24 weeks | score on a scale | MEAN | |
| SECONDARY | Successful Initial Response | 1 week after treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Complete Ulceration Healing Time | from the first dosage of propranolol or atenolol until complete healing ofthe hemangioma ulceration. | weeks | MEAN | |
| SECONDARY | Rebound Rate | between weeks 24 and 96 | Data only included patients who attempted to discontinue β-blockers according to the treatment plan between weeks 24 and 96 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Complete/Nearly Complete Response (96 Week) | 96 week | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Primary Outcome Measure Was Any Response at 6 Months | Propranolol | 178 | Participants | ||
| The Primary Outcome Measure Was Any Response at 6 Months | Atenolol | 173 | Participants | ||
| Hemangioma Activity Score (HAS) | Propranolol | Baseline | 4.61 | Standard Deviation 0.82 | score on a scale |
| Hemangioma Activity Score (HAS) | Atenolol | Baseline | 4.54 | Standard Deviation 0.76 | score on a scale |
| Hemangioma Activity Score (HAS) | Propranolol | Week 1 | 3.31 | Standard Deviation 0.72 | score on a scale |
| Hemangioma Activity Score (HAS) | Atenolol | Week 1 | 3.47 | Standard Deviation 0.75 | score on a scale |
| Hemangioma Activity Score (HAS) | Propranolol | Week 4 | 2.42 | Standard Deviation 0.60 | score on a scale |
| Hemangioma Activity Score (HAS) | Atenolol | Week 4 | 2.33 | Standard Deviation 0.65 | score on a scale |
| Hemangioma Activity Score (HAS) | Propranolol | Week 12 | 1.54 | Standard Deviation 0.79 | score on a scale |
| Hemangioma Activity Score (HAS) | Atenolol | Week 12 | 1.54 | Standard Deviation 0.72 | score on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Propranolol | 190 | |
| Overall Study | STARTED | Atenolol | 187 | |
| Overall Study | COMPLETED | Propranolol | 184 | |
| Overall Study | COMPLETED | Atenolol | 182 | |
| Overall Study | NOT COMPLETED | Propranolol | 6 | |
| Overall Study | NOT COMPLETED | Atenolol | 5 |
Source ClinicalTrials.gov
Adverse events34
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 | Diarrhea | Gastrointestinal disorders | Propranolol | 25 | 190 | |
| other | Diarrhea | Gastrointestinal disorders | Atenolol | 27 | 187 | |
| other | Sleep disturbance | Nervous system disorders | Propranolol | 25 | 190 | |
| other | Sleep disturbance | Nervous system disorders | Atenolol | 9 | 187 | |
| other | Agitation | Psychiatric disorders | Propranolol | 16 | 190 | |
| other | Agitation | Psychiatric disorders | Atenolol | 5 | 187 | |
| other | Cool extremities | Blood and lymphatic system disorders | Propranolol | 14 | 190 | |
| other | Cool extremities | Blood and lymphatic system disorders | Atenolol | 6 | 187 | |
| other | Bradycardia | Cardiac disorders | Propranolol | 13 | 190 | |
| other | Bradycardia | Cardiac disorders | Atenolol | 9 | 187 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Propranolol | 0 | 190 |
| Total, all-cause mortality | Atenolol | 0 | 187 |
| Total, other adverse events | Propranolol | 128 | 190 |
| Total, other adverse events | Atenolol | 80 | 187 |
| Total, serious adverse events | Propranolol | 5 | 190 |
| Total, serious adverse events | Atenolol | 3 | 187 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Propranolol vs Atenolol: Rebound Rate | Trial comparisons |
| Propranolol vs Atenolol: Successful Initial Response | Trial comparisons |
| Propranolol vs Atenolol: The Primary Outcome Measure Was Any Response at 6 Months | Trial comparisons |
| Propranolol vs Atenolol: deaths from any cause | Trial comparisons |
| Propranolol vs Atenolol: Number of Participants With Complete/Nearly Complete Response (96 Week) | Trial comparisons |
| Propranolol vs Atenolol: serious adverse events | 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/NCT02342275
GET https://conductscience.org/api/trials/v1/NCT02342275/events?page=2