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Efficacy and safety of the topical triple regimen of spreadable SHS-mediated low-dose 5-fluorouracil transdermal delivery combined with compound heparin sodium allantoin gel for hypertrophic scars treatment: A Prospective, Randomized Controlled clinical trial

Efficacy and safety of the topical triple regimen of spreadable SHS-mediated low-dose 5-fluorouracil transdermal delivery combined with compound heparin sodium allantoin gel for hypertrophic scars treatment: A Prospective, Randomized Controlled clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079689
Enrollment
Unknown
Registered
2024-01-09
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-01-14

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

Conditions

Hypertrophic Scars

Interventions

Study Group 1:CHSAG+SHS
Study Group 2:low-dosage 5-FU + CHSAG
Study Group 3:low-dosage 5-FU + SHS+ CHSAG
Study Group 4:Medium-dosage 5-FU + SHS+ CHSAG

Sponsors

Langzhong peoples' hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Scars should be confirmed in line with the morphological characteristics of hypertrophic scars, in line with the diagnostic criteria of hypertrophic scars : its distinctive features contain that the scar is prominent in the normal skin tissue 1-4mm and limited to the extent of the lesion, consist of obvious congestion, visible fading after pressing and tough or harder texture, the patients state no significant recent regression phenomenon; 2. 20-50 years; 3. Area <= 10 cm^2, the maximum length is greater than 10 mm; 4. This study would be approved by the Ethics Committee of the hospital. The patient will be informed in detail of the advantages and disadvantages that might arise before and after medication. The patient and family members should voluntarily choose the treatment and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Complicated with severe hypertrophic scar ulceration and infection; 2. Patients with skin melanoma, non-melanoma skin malignant tumors, and precancerous lesions, combined with severe systemic infectious diseases, malignant tumors, or immunosuppressive diseases; 3. Diagnosed as keloid, scar hyperplasia range beyond the original injury area, tumor growth; 4. Combined with hepatitis B virus or HIV virus infection; 5. Patients who are allergic or allergic to the pharmaceutical ingredients used in this study; 6. Patients with photosensitive diseases such as systemic lupus erythematosus and porphyria; patients with coagulation dysfunction diseases such as idiopathic thrombocytopenic purpura; patients with hemorrhagic diseases or taking anticoagulant drugs; 7. Those who are taking photosensitive drugs or have taken vitamin A acid drugs within half a year; 8. Patients who underwent other major surgery within the last 6 months; scar area within 6 months to accept surgical resection, isotope application, local closure,Local fluorouracil injection, laser, and other treatment; 9. Women who are pregnant or lactating, or who have a recent planned pregnancy; 10. Poor clinical compliance; 11. Patients who had high expectations of treatment or refused to participate in the study; 12. Patients with underlying diseases such as hypertension, hyperthyroidism and endocrine disorders; 13. Those with connective tissue diseases or diseases that may affect connective tissue metabolism; patients with glaucoma or cataract; 14. Combined with severe heart, liver, brain, lung, spleen, kidney, and other important organ dysfunction, combined with coronary atherosclerotic heart disease ( coronary heart disease ), nephrotic syndrome, diabetes, and other serious medical diseases, water loss or ( and ) acid-base, electrolyte imbalance; 15. Have received medication prior to enrollment that affected the results of this study; 16. Patients with a history of mental illness, alcoholics, and the infirm; 17. Patients and (or) family members do not agree to join the clinical trials; 18. Patients who have developed chickenpox or herpes or acne or other inflammatory skin conditions on the area of skin where treatment is required; 19. Patients had a history of abnormal pigmentation; 20. Patients with more severe or no significant improvement in skin scar tissue after multiple treatments were excluded from the study.

Design outcomes

Primary

MeasureTime frame
POSAS Scar Evaluation Scale (Patient + Doctor);Modified Vancouver scar scale;

Secondary

MeasureTime frame
five points patient and observer scar assessment scal;

Countries

China

Contacts

Public ContactMu Wenhai

Langzhong peoples' hospital

490961045@qq.com+86 180 8690 1017

Outcome results

None listed

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