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Safety and Efficacy of Electromagnetic-based Transdermal Drug Delivery of Mannitol compare to Sterile Water in Acne Scar in Asian a Split Face Analysis

Safety and Efficacy of Electromagnetic-based Transdermal Drug Delivery of Mannitol compare to Sterile Water in Acne Scar in Asian a Split Face Analysis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251020004
Enrollment
30
Registered
2025-10-20
Start date
2025-11-03
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

Patients with facial acne scar. acne scar, mannitol, sterile water

Interventions

Patients were injected using electromagnetic-based transdermal delivery with Mannitol at acne scar for 3 session, one month apart. Then they were instructed to follow up at 1, 3 and 6 months after com
Active Comparator Drug,Active Comparator Drug
Electromagnetic-based transdermal delivery of Mannitol,Electromagnetic-based transdermal delivery of sterile water

Sponsors

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

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged between 20 and 60 years, of any gender. 2. Patients with moderate or greater facial atrophic acne scars, as assessed by the Qualitative Global Scarring Grading System. 3. Patients who voluntarily consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Patients who are pregnant or breastfeeding. 2. Patients with a history of collagen-related disorders, such as Cushing's syndrome or Ehlers-Danlos syndrome. 3. Patients with facial dermatitis, wounds, or active skin infections. 4. Patients who have cancer, are currently undergoing cancer treatment, or have skin cancer in the treatment area. 5. Patients with a history of immunodeficiency, including those infected with HIV or diagnosed with AIDS. 6. Patients with a history of abnormal photosensitivity. 7. Patients who have received facial treatments such as dermal fillers, botulinum toxin, collagen biostimulators, platelet-rich plasma (PRP), or thread lifting within 6 months prior to study participation. 8. Patients who have undergone laser treatment for facial acne scars within 6 months prior to study participation. 9. Patients with a history of keloid scars or skin lesions in the treatment area. 10. Patients who have used vitamin A or its derivatives within 6 months prior to study participation. 11. Patients with a history of psychiatric disorders, as assessed by a qualified physician. 12. Patients who do not consent to photographic documentation for treatment evaluation. 13. Patients with a history of allergy to local anesthetics. 14. Patients with a pacemaker or any implanted electrical device that may be affected by electromagnetic equipment. 15. Patients with a bleeding disorder or those currently taking anticoagulant medication. 16. Patients who are taking systemic corticosteroids or using topical steroid cream in the treatment area.

Design outcomes

Primary

MeasureTime frame
Acne scar depression volume analysis Baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1 month after 3rd treatment, 3 and 6 months after complete the treatment. Antera 3D,Texture improvement Baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1 month after 3rd treatment, 3 and 6 months after complete the treatment. Antera 3D,Goodman and Baron's Quantitative Global Acne Scarring Grading System Baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1 month after 3rd treatment, 3 and 6 months after complete the treatment. Goodman and Baron's Quantitative Global Acne Scarring Grading System

Secondary

MeasureTime frame
Melanin and erythema index Baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1 month after 3rd treatment, 3 and 6 months after complete the treatment. mexameter,Physician improvement scale Baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1 month after 3rd treatment, 3 and 6 months after complete the treatment. Quartile scale,Patient improvement scale Baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1 month after 3rd treatment, 3 and 6 months after complete the treatment. Quartile scale,Pain score immediate Visual analog scale,Safety Baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1 month after 3rd treatment, 3 and 6 months after complete the treatment. 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