NCT05488860

Brief Summary

Piezoelectric drived microneedling treats refractory skin disorders using hollow microneedles assisted by ultrasound. Mechanically, the injection of medicine by hollow microneedling could makes the distribution of medicine more evenly. And the addition of ultrasound technique improves the effectiveness of microneedling. Investigators plan to conduct a pilot study to investigate the efficacy of using piezoelectric drived microneedles in treating refractory skin diseases.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 30, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 1, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

August 5, 2022

Status Verified

July 1, 2022

Enrollment Period

1.9 years

First QC Date

August 1, 2022

Last Update Submit

August 4, 2022

Conditions

Skin DiseasesHypertrophic ScarKeloidPlantar WartWartsSkin Tumor

Keywords

MicroneedlingUltrasoundRefractory skin diseasesPiezoelectric drived

Outcome Measures

Primary Outcomes (2)

  • Short-term response

    This is a qualitative item which should be evaluated by comparing the general images and dermoscopic images pre-treatment and post-treatment carefully.

    1 week after treatment

  • Long-term response

    This is a qualitative item which should be evaluated by comparing the general images and dermoscopic images pre-treatment and post-treatment carefully.

    1 month after treatment

Secondary Outcomes (2)

  • Pain score during treatment

    Immediately

  • POSAS(The Patient and Observer Scar Assessment Scale) score

    1 month after treatment

Study Arms (2)

Traditional injection

ACTIVE COMPARATOR

Intralesional injection of drug by traditional injection needle. This is the traditional approach for drug delivery recommended by international guidelines for each skin diseases.

Drug: Triamcinolone acetonide(scar)/5-ALA(others)

Piezoelectric drived microneedling

EXPERIMENTAL

Intralesional injection of drug by piezoelectric drived microneedles.

Procedure: Piezoelectric drived microneedlingDrug: 5-ALA (a photosensitizer for photodynamic therapy).

Interventions

Triamcinolone acetonide(scar)/5-ALA(others)DRUG

For scar, the drug is triamcinolone acetonide.

Also known as: Intralesional drug delivery
Traditional injection
Piezoelectric drived microneedlingPROCEDURE

Piezoelectric drived microneedling

Piezoelectric drived microneedling
5-ALA (a photosensitizer for photodynamic therapy).DRUG

For other diseases, the drug is 5-ALA (a photosensitizer for photodynamic therapy).

Piezoelectric drived microneedling

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 16 years
  • Diagnosed by 2 or more professional dermatologists
  • Willing to underwent a new treatment modality
  • Follow up is easy to conduct

You may not qualify if:

  • Poor general condition
  • Bleeding tendency
  • Allergy to drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangya Hospital

Changsha, 410008, China

RECRUITING

MeSH Terms

Conditions

Skin DiseasesCicatrix, HypertrophicKeloidWartsSkin Neoplasms

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsCollagen DiseasesConnective Tissue DiseasesPapillomavirus InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralTumor Virus InfectionsSkin Diseases, InfectiousNeoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Comparison is designed in each participant. For each individual, two similar hypertrophic scar/keloid or a single hypertrophic scar/keloid is randomly assigned into traditional injection group or piezoelectric divied microneedling group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2022

First Posted

August 5, 2022

Study Start

July 30, 2022

Primary Completion

June 30, 2024

Study Completion

July 31, 2024

Last Updated

August 5, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)