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A Comprehensive Study of Comparative Histopathology in Human Dermatological Biostimulators for Tissue Regeneration

A Comprehensive Study of Comparative Histopathology in Human Dermatological Biostimulators for Tissue Regeneration

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251123001
Enrollment
10
Registered
2025-11-23
Start date
2025-11-24
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Patient with excess abdominal skin who intend to undergo abdominoplasty. abdominoplasty, Biostimulators, Tissue Regeneration

Interventions

Patients were injected with hyaluronic acid (Volite, Belotero Revive, Profhilo) and normal saline solution into abdominal sites. Each patient received injections in 7 sessions at 12, 9, 6, 3, 2, 1 mon
Hyaluronic acid,Polynucleotides,Polydioxanone, Polycaprolactone, Poly-L-lactic acid,Poly-D,L-lactic Acid,Calcium hydroxyapatite

Sponsors

Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged 30 to 60 years, both male and female, who are in good general health. 2. Volunteers who intend to undergo surgical removal of excess abdominal skin.

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding women, or patients with a positive urine pregnancy test. 2. Patients with a history of serious underlying diseases, such as platelet disorders, coagulation abnormalities, anemia, renal disease, hepatic disease, cancer, or autoimmune deficiency disorders. 3. Patients who smoke or have a history of heavy alcohol consumption 4. Patients with dermatitis, wounds, or skin infections in the abdominal area. 5. Patients with a history of hormone use, injectable or oral contraceptives, or regular use of NSAIDs. 6. Patients with a history of using medications that affect blood coagulation, such as aspirin or anticoagulants. 7. Patients with abdominal striae. 8. Patients with a history of abdominal lifting procedures or laser treatments within 6 months prior to enrollment. 9. Patients with a history of keloid scarring. 10. Patients diagnosed with psychiatric disorders by a psychiatrist. 11. Patients who are likely to undergo rapid weight loss. 12. Patients requiring abdominal surgery during the study period. 13. Patients with a history of allergy to local anesthetics or general anesthetics, as general anesthesia is required.

Design outcomes

Primary

MeasureTime frame
Compare histopathological changes in the skin related to collagen production, fibroblast activity, elastin, aquaporin, blood vessels, and sweat glands after abdominoplastic surgery biopsy, biological markers,Evaluate the time course of histopathological changes in the skin related to collagen production, fibroblast activity, elastin, blood vessels, and sweat glands after abdominoplastic surgery biopsy, biological markers

Secondary

MeasureTime frame
Pain score 12, 9, 6, 3, 2, 1 months and 2 weeks before surgery Visual analog scale ,Safety 12, 9, 6, 3, 2, 1 months and 2 weeks before surgery Adverse event

Countries

Thailand

Contacts

Public ContactRungsima Wanitphakdeedecha

Faculty of Medicine Siriraj Hospital, Mahidol University

rungsima.wan@mahidol.ac.th024197000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026