Skin DiseasesNCT05488860
Piezoelectric Drived Microneedling in Treating Refractory Skin Diseases
A study testing Triamcinolone acetonide(scar)/5-ALA(others), Piezoelectric drived microneedling and 5-ALA (a photosensitizer for photodynamic therapy). in people with Skin Diseases and Hypertrophic Scar, run by Xiangya Hospital of Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Diseases, Hypertrophic Scar, Keloid
- What is being tested?
- Triamcinolone acetonide(scar)/5-ALA(others), Piezoelectric drived microneedling and 5-ALA (a photosensitizer for photodynamic therapy).
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2022to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age over 16 years
- Diagnosed by 2 or more professional dermatologists
- Willing to underwent a new treatment modality
- Follow up is easy to conduct
Who cannot join
- Poor general condition
- Bleeding tendency
- Allergy to drug
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital
Changsha, 410008
Zixi Jiang, 13278883845, jiangzixi@csu.edu.cn
About this study
Official title: Piezoelectric Drived Microneedling in Treating Refractory Skin Diseases: A Pilot Study
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.
Read the detailed description
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. Investigators accept participants of hypertrophic scar, keloid and warts. For participants who are not candidates for traditional surgery, investigators will consider to accept carefully.
- Conditions
- Skin Diseases, Hypertrophic Scar, Keloid, Plantar Wart, Warts, Skin Tumor
- Being tested
- Triamcinolone acetonide(scar)/5-ALA(others), Piezoelectric drived microneedling, 5-ALA (a photosensitizer for photodynamic therapy).
- Keywords
- Microneedling, Ultrasound, Refractory skin diseases, Piezoelectric drived
- Medical subject headings
- Skin Diseases, Cicatrix, Hypertrophic, Keloid, Warts, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone acetonide(scar)/5-ALA(others)Drug
Also called Intralesional drug delivery
For scar, the drug is triamcinolone acetonide.
Piezoelectric drived microneedlingProcedure or surgery
Piezoelectric drived microneedling
5-ALA (a photosensitizer for photodynamic therapy).Drug
For other diseases, the drug is 5-ALA (a photosensitizer for photodynamic therapy).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Triamcinolone acetonide(scar)/5-ALA(others) |
| Piezoelectric drived microneedling | Experimental | Intralesional injection of drug by piezoelectric drived microneedles. Receives: Procedure: Piezoelectric drived microneedling; Drug: 5-ALA (a photosensitizer for photodynamic therapy). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 month after treatment
Secondary outcomes (2)
Pain score during treatment
Using visual analogue scale (score 0-10, 0=no pain, 10=unbearable pain) to evaluate the level of pain
Measured: Immediately
POSAS(The Patient and Observer Scar Assessment Scale) score
A widely used scar scale for evaluating the severity of scar by both patients and dermatologists. Score ranged from 11 to 110. The higher score means severer condition of scar.
Measured: 1 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start30 Jul 2022 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin DiseasesStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488860
- Sponsor's protocol ID
- XiangyaDerm0002
- Status last verified
- Jul 2022
- First submitted
- 1 Aug 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jiang Z, Chen Z, Wu H, Ye K, Dong Z, Hu W, Su J, Chen Z, Chen X, Zhao S. Synergistic Intervention of Piezo1 Activation and Fibrous Tissue Remodeling to Ease Side Effects of Intralesional Therapy for Keloids. Adv Healthc Mater. 2026 Jan;15(4):e03332. doi: 10.1002/adhm.202503332. Epub 2025 Oct 2.
PubMed 41039790
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piezoelectric Drived Microneedling in Treating Refractory Skin Diseases: A Pilot Study
- ClinicalTrials.gov ID
- NCT05488860
- Acronym / sponsor ID
- XiangyaDerm0002
- Conditions
- Skin Diseases, Hypertrophic Scar, Keloid, Plantar Wart, Warts, Skin Tumor
- Keywords
- Microneedling, Ultrasound, Refractory skin diseases, Piezoelectric drived
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 30 Jul 2022 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 5 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Investigators accept participants of hypertrophic scar, keloid and warts. For participants who are not candidates for traditional surgery, investigators will consider to accept carefully.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Traditional injection | Active comparator | Drug: Triamcinolone acetonide(scar)/5-ALA(others)Intralesional injection of drug by traditional injection needle. This is the traditional approach for drug delivery recommended by international guidelines for each skin diseases. |
| Piezoelectric drived microneedling | Experimental | Procedure: Piezoelectric drived microneedling, Drug: 5-ALA (a photosensitizer for photodynamic therapy).Intralesional injection of drug by piezoelectric drived microneedles. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 16 years
- Diagnosed by 2 or more professional dermatologists
- Willing to underwent a new treatment modality
- Follow up is easy to conduct
Key exclusion criteria (3 listed)
- Poor general condition
- Bleeding tendency
- Allergy to drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triamcinolone acetonide(scar)/5-ALA(others)Also: Intralesional drug deliveryFor scar, the drug is triamcinolone acetonide. | Drug | Traditional injection |
| Piezoelectric drived microneedlingPiezoelectric drived microneedling | Procedure or surgery | Piezoelectric drived microneedling |
| 5-ALA (a photosensitizer for photodynamic therapy).For other diseases, the drug is 5-ALA (a photosensitizer for photodynamic therapy). | Drug | Piezoelectric drived microneedling |
Primary outcome
Short-term response
Time frame: 1 week after treatment
This is a qualitative item which should be evaluated by comparing the general images and dermoscopic images pre-treatment and post-treatment carefully.
Long-term response
Time frame: 1 month after treatment
This is a qualitative item which should be evaluated by comparing the general images and dermoscopic images pre-treatment and post-treatment carefully.
2 secondary outcomes
Pain score during treatment
Time frame: Immediately
POSAS(The Patient and Observer Scar Assessment Scale) score
Time frame: 1 month after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Derived from this study: PubMed 41039790Jiang Z, Chen Z, Wu H, Ye K, Dong Z, Hu W, Su J, Chen Z, Chen X, Zhao S. Synergistic Intervention of Piezo1 Activation and Fibrous Tissue Remodeling to Ease Side Effects of Intralesional Therapy for Keloids. Adv Healthc Mater. 2026 Jan;15(4):e03332. doi: 10.1002/adhm.202503332. Epub 2025 Oct 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triamcinolone acetonide(scar)/5-ALA(others), Piezoelectric drived microneedling and 5-ALA (a photosensitizer for photodynamic therapy). in people with Skin Diseases and Hypertrophic Scar, run by Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term response (time frame: 1 week after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05488860, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.