Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03181984 |
Recruitment Status :
Recruiting
First Posted : June 9, 2017
Last Update Posted : August 13, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Port-Wine Stain | Drug: Hemoporfin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1500 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain |
Actual Study Start Date : | August 31, 2017 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | December 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: Hemoporfin |
Drug: Hemoporfin
Hemoporfin mediated photodynamic therapy |
- Number of participants with treatment-related adverse events [ Time Frame: 96 weeks after hemoporfin application ]
- Satisfaction rating of the overall treatment by subjects [ Time Frame: 8, 24 and 96 weeks after hemoporfin application ]
- Satisfaction rating of the overall treatment by investigators [ Time Frame: 8 weeks after hemoporfin application ]
- Response rate [ Time Frame: 8 weeks after hemoporfin application ]proportion of patients achieving at least some improvement (color blanching from the baseline >= 20%)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 14 Years to 65 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age range: 14 to 65 years-old;
- Clinically diagnosed of Port-wine Stain;
- Patients receiving hemoporfin based upon the clinical judgment of the investigator;
- Written informed consent signed and agreed to receive periodic follow-up
Exclusion Criteria:
- Allergy to porphyrins and analogues; Photosensitivity; Porphyria; Allergic constitution;
- Scar diathesis;
- Pregnancy or unwilling to adopt reliable contraceptive measures during the month after drug application;
- Be judged not suitable to participate the study by the investigators

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03181984
Contact: Jining Tao | +86 21 58953355 | jntao@d-zj.com |
China, Heilongjiang | |
The 2nd Affiliated Hospital of Harbin Medical University | Recruiting |
Harbin, Heilongjiang, China | |
China, Herbei | |
Affiliated Hospital of Hebei Medical College of traditional Chinese Medicine | Recruiting |
Shijiazhuang, Herbei, China | |
China, Jiangsu | |
Wuxi People's Hospital | Recruiting |
Wuxi, Jiangsu, China | |
China, Sichuan | |
West China Hospital, Sichuan University | Recruiting |
Chengdu, Sichuan, China | |
China | |
Peking University First Hospital | Recruiting |
Beijing, China, 100034 | |
Contact: Ke Wang +86 10 83573066 | |
PLA Army General Hospital | Recruiting |
Beijing, China | |
Shanghai Dermatology Hospital | Recruiting |
Shanghai, China |
Principal Investigator: | Xuejun Zhu | Peking University First Hospital | |
Study Director: | Jining Tao | Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. |
Responsible Party: | Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT03181984 |
Other Study ID Numbers: |
HMME-S1612 |
First Posted: | June 9, 2017 Key Record Dates |
Last Update Posted: | August 13, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hemangioma, Capillary Port-Wine Stain Skin Abnormalities Congenital Abnormalities Skin Diseases |
Hemangioma Neoplasms, Vascular Tissue Neoplasms by Histologic Type Neoplasms |