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A self-controlled study comparing the clinical efficacy of punch excision combined with CO2 manual fractional laser in the treatment of keloids

A self-controlled study comparing the clinical efficacy of punch excision combined with CO2 manual fractional laser in the treatment of keloids

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091727
Enrollment
Unknown
Registered
2024-11-01
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-11-04

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

Conditions

keloid

Interventions

Ring drill+BI+5-FU group:punch excision
MFT+BI+5-F group:CO2 manual fractional laser

Sponsors

Central hospital affiliated to shandong first medical university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1)Participants diagnosed with keloids by the researchers may be treated with betamethasone and 5-fluorouracil injection, CO2 manual fractional laser, or punch excision; (2)maximum diameter = 2 cm but = 5 cm; (3) symmetrical keloids or two keloids with similar morphology at a single site; (4) adult patients aged 18 years or older; (5) Fitzpatrick skin types II-IV; (6) seeking improvement in keloid appearance; and (7) willingness to sign an informed consent form and agree to complete follow-up visits.

Exclusion criteria

Exclusion criteria: (1)Active skin conditions: Subjects with active keloid infections (e.g., ulcers, abscesses), non-healing wounds, or progressive skin diseases (e.g., vitiligo, psoriasis); (2)Recent treatments or surgeries: Subjects who have received or are scheduled to receive treatments or surgeries that may interfere with outcome assessment within the past 3 months (e.g., betamethasone, 5-fluorouracil, verapamil, botulinum toxin, laser therapy, or radiation therapy); (3)Allergies or contraindications: Subjects with known allergies or contraindications to betamethasone, 5-fluorouracil, or lidocaine; (4)Hemostatic disorders: Subjects with a history of bleeding disorders or those who have used or are planning to use anticoagulants, antiplatelet agents, or thrombolytic agents (e.g., warfarin, aspirin) within 14 days prior to screening; (5) Pregnancy or lactation: Women who are pregnant, lactating, or planning to become pregnant (or male subjects unwilling to use adequate contraception) or with a positive pregnancy test at screening;(6) Serious medical conditions: Subjects with a history of serious organ disease or active autoimmune disease; (7)Concurrent clinical trials: Subjects who have participated in any other clinical trial within the past 30 days; (8)Other medical conditions: Subjects with other systemic illnesses or abnormal laboratory findings that, in the investigator's opinion, would make them unsuitable for the study;(9) Inability to comply: Subjects who are unable to communicate or comply with the study protocol; (10)Other reasons: Subjects who, in the investigator's opinion, are not suitable for the study for any other reason.

Design outcomes

Primary

MeasureTime frame
Vancouver Scar Scale ;

Secondary

MeasureTime frame
Patient and Observer Scar Assessment Scale;

Countries

China

Contacts

Public Contactsujieyan

Central hospital affiliated to shandong first medical university

sujieyansdu@163.com+86 158 6669 9970

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026