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The Study to Evaluate the Efficacy and Safety of Calcium Hydroxylapatite (CaHA) Injection for Facial Rejuvenation in Thai Patients.

The Study to Evaluate the Efficacy and Safety of Calcium Hydroxylapatite (CaHA) Injection for Facial Rejuvenation in Thai Patients.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251015002
Enrollment
27
Registered
2025-10-15
Start date
2024-10-15
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

Health Condition(s) or Problem(s) Studied : Patients with photoaging skin calcium hydroxylapatite, photoaging

Interventions

Patients were injected with calcium hydroxyapatite for 1 session. Then they were instructed to follow up at 1, 3, 6, 9 and 12 months after treatment.
Experimental Device
Cacium hydroxyapatite injection

Sponsors

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

Eligibility

Sex/Gender
All
Age
25 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Male or female Thai participants aged 25 - 60 years. 2. Volunteers who have photoaging skin evaluated by a dermatologic surgery specialist using the Glogau classification of photoaging at moderate or higher level.

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding women. 2. Participants with a history of platelet disorders, coagulation abnormalities, anemia, liver disease, malignancy, or immunodeficiency. 3. Participants who smoke or consume alcohol excessively. 4. Participants with dermatitis, wounds, or active facial skin infections. 5. Participants with a history of allergy to local anesthetics. 6. Participants who regularly take hormonal medications, injectable or oral contraceptives, or NSAIDs. 7. Participants taking medications that affect blood coagulation (e.g., aspirin, anticoagulants). 8. Participants who underwent facial lifting procedures (energy-based devices or thread lift) within 6 months before enrollment. 9. Participants who received facial filler injections within 6 months before enrollment. 10. Participants who received platelet-rich plasma (PRP) facial injections within 6 months before enrollment. 11. Participants who received facial botulinum toxin injections within 6 months before enrollment. 12. Participants who underwent collagen-stimulating facial lasers e.g., picosecond laser, erbium:YAG, Fractora, or E-matrix - within 6 months before enrollment. 13. Participants with a history of hypertrophic scars or keloids. 14. Participants diagnosed with psychiatric disorders by a psychiatrist. 15. Participants with a known allergy to calcium hydroxylapatite.

Design outcomes

Primary

MeasureTime frame
Wrinkle depth Baseline, 1, 3, 6, 9 and 12 months Antera,Wrinkle indentation index Baseline, 1, 3, 6, 9 and 12 months Antera,Texture roughness Baseline, 1, 3, 6, 9 and 12 months Antera

Secondary

MeasureTime frame
Volume Change Baseline, 1, 3, 6, 9 and 12 months Vectra H2,Volume Change Baseline, 1, 3, 6, 9 and 12 months Quantificare,R0 Baseline, 1, 3, 6, 9 and 12 months Cutometer,R2 Baseline, 1, 3, 6, 9 and 12 months Cutometer,Hydration level Baseline, 1, 3, 6, 9 and 12 months Corneometer,Redness Baseline, 1, 3, 6, 9 and 12 months Mexameter,Pigmentation Baseline, 1, 3, 6, 9 and 12 months Mexameter,Individual typology angle Baseline, 1, 3, 6, 9 and 12 months Colorimeter,Sebum level Baseline, 1, 3, 6, 9 and 12 months Sebumeter,Safety Baseline, 1, 3, 6, 9 and 12 months Adverse event,Physician improvement scale Baseline, 1, 3, 6, 9 and 12 months percent improvement,Patient Improvement scale Baseline, 1, 3, 6, 9 and 12 months percent improvement,Pain score Treatment visit Visual analog scale

Countries

Thailand

Contacts

Public ContactRungsima Wanitphakdeedecha

Faculty of Medicine Siriraj Hospital

rungsima.wan@mahidol.ac.th6624197000

Outcome results

None listed

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