Efficacy and Safety of Different Initial Doses of Oral Propranolol in the Treatment of Ulcerated Infantile Hemangioma

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
AgeUp to 1
SponsorWest China Hospital

About this trial

The main objective of this study was to determine the efficacy of different doses of propranolol in the treatment of ulcerattion infantile hemangioma (IH).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

all patients with ulcer IH;

children with ulcer IH treated with propranolol.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • propranolol

    Drug

    different dose

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: low doseExperimental treatment 1 intervention
Group B: high doseActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to ulcer healing

Time from the start of treatment with propranolol to complete ulcer healing

Time frame
0.5 years

Secondary outcomes

1

The resolution of IH at month 6 after treatment

complete resolution/complete resolution/partial resolution/no effect/withdrawal from treatment

Time frame
0.5 years
2

adverse events

The incidence of adverse events in the two groups after oral propranolol at different doses

Time frame
0.5 years

Other outcomes

Sponsors and contacts

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