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Innovative Interstitial Injection Therapy as an Alternative to Surgery for Inhibiting Port-Wine Stain-Associated Facial and Labial Hypertrophy and Asymmetrical Deformity: A Single-Center, Randomized Controlled Trial

Innovative Interstitial Injection Therapy as an Alternative to Surgery for Inhibiting Port-Wine Stain-Associated Facial and Labial Hypertrophy and Asymmetrical Deformity: A Single-Center, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128083
Enrollment
Unknown
Registered
2026-07-14
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Port wine stain, PWS

Interventions

Pingyangmycin Injection Group:Intralesional interstitial injection of Pingyangmycin
Control Group:An equal volume of placebo mixture

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Patients with facial and lip enlargements and asymmetrical deformities associated with port-wine stains who meet the diagnostic criteria for vascular malformations in the guidelines for hemangioma and vascular malformation treatment, and have been confirmed by at least three clinicians. 2. Aged 8-50 years (including 8 and 50), any gender; 3. Have not received any other injection treatments in the past 3 months;

Exclusion criteria

Exclusion criteria: 1. People with facial infections, a history of skin cancer, weakened immune systems, or poor wound healing; 2. Women who are pregnant or breastfeeding; 3. Those with serious heart, brain, lung, liver, or kidney problems, a history of mental illness, or recent history of heavy drinking or drug abuse; 4. Participants who don’t want to sign the informed consent form or won’t cooperate with medical staff; 5. Patients currently participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Degree of reduction in hypertrophic lesion volume;

Secondary

MeasureTime frame
Micro-ultrasound detection of lesion thickness and blood flow;3D scanning to evaluate surface volume;Visual Analog Scale (VAS) scoring method;Objective detection of lesion color using a photometer;

Countries

China

Contacts

Public ContactMa Gang

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

docmagang@126.com+86 21 2327 1699

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026