Acne AtrophicaPhase 4NCT05861063
The Efficacy and Safety of Dezocine Pretreatment for Pain Relief in Acne Scar Treatment of Fractional CO2 Laser
A Phase 4 study testing Fractional CO2 laser and Dezocine in people with Acne Atrophica, run by Xijing Hospital at 1 site in China.
Trial summary
The Efficacy and Safety of Dezocine Pretreatment for Pain Relief in Acne Scar Treatment of Fractional CO2 Laser Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acne Atrophica
- What is being tested?
- Fractional CO2 laser and Dezocine
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- 11 Feb 2023to 31 Dec 2024
- Phase
- Phase 4
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18-60 years old, regardless of gender;
- Clinical diagnosis of atrophic acne scars;
- Planning to undergo ultra-pulsed CO2 lattice laser therapy;
- The patient agrees to participate in this experiment and signs an informed consent form
Who cannot join
- Those who take sedative drugs for a long time;
- Patients with sleep apnea syndrome, previous history of hypertension, and blood pressure greater than 160/100mmHg
- People with severe heart and lung diseases, liver and kidney diseases, psychosis, pregnancy, and communication disorders;
- Persons who are known to be allergic to the main drug or any of the excipients in Dezocine injection;
- Increased intracranial pressure or head injury;
- Acute and chronic alcoholism;
- People with hypotension, hypothyroidism, acute episodes of asthma, and epilepsy
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dermatology Derpartment of Xijing Hospital
Xi'an, Shaanxi, 710032
Gang Wang, prof, +8684775401, xjwgang@fmmu.edu.cn
About this study
Official title: The Efficacy and Safety of Dezocine Pretreatment for Pain Relief in Acne Scar
The Efficacy and Safety of Dezocine Pretreatment for Pain Relief in Acne Scar Treatment of Fractional CO2 Laser
- Conditions
- Acne Atrophica
- Being tested
- Fractional CO2 laser, Dezocine
- Keywords
- Acne Scar, Dezocine, Pain Relief, Fractional CO2 Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional CO2 laserDevice
Also called paronosetron hydrochloride and lidocaine cream
All patients were given oral administration of 0.5mg paronosetron hydrochloride and lidocaine cream 1 hour before surgery. After cleaning and disinfection, fractional CO2 laser treatment was given. Among them, the fractional CO2 laser laser (American Medical Laser company) selected relatively constant energy parameters in the treatment
DezocineDrug
Desocine injection was injected intravenously half an hour before surgery (10ml normal saline was added for more than 30 seconds)
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | The patients were divided into 3 groups based on different dosages of Dezocine injection, with 35 patients in each group: Group 1: Dezocine low-dose group, Group 2: Dezocine high-dose group; Group 3: Blank control group (normal saline). Receives: Device: Fractional CO2 laser |
| Dezocine low dose group | Experimental | The patients were divided into 3 groups based on different dosages of Dezocine injection, with 35 patients in each group: Group 1: Dezocine low-dose group, Group 2: Dezocine high-dose group; Group 3: Blank control group (normal saline). Receives: Device: Fractional CO2 laser; Drug: Dezocine |
| Dezocine high dose group | Experimental | The patients were divided into 3 groups based on different dosages of Dezocine injection, with 35 patients in each group: Group 1: Dezocine low-dose group, Group 2: Dezocine high-dose group; Group 3: Blank control group (normal saline). Receives: Device: Fractional CO2 laser; Drug: Dezocine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Score for Pain
0 was classified as painless and 10 was classified as unbearable pain. Marks were made on the corresponding parts of the ruler and scores were scored according to the degree of patient's feeling
Measured: 24 hours
Hemodynamic parameters
diastolic blood pressure (DBP), systolic blood pressure (SBP)
Measured: 24 hours
Heart rate (HR)
Hemodynamic parameters
Measured: 24 hours
oxygen saturation (SpO2)
Hemodynamic parameters
Measured: 24 hours
Secondary outcomes (1)
Occurrence of Adverse Reactions
Nausea, vomiting，dizziness，respiratory depression
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start11 Feb 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne AtrophicaStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gang Wang, Prof, Principal investigator, Dermatology Derpartment of Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861063
- Sponsor's protocol ID
- XijingH-PF-20232019-F-1
- Status last verified
- Feb 2023
- First submitted
- 17 Apr 2023
- Last updated
- 16 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Dezocine Pretreatment for Pain Relief in Acne Scar
- ClinicalTrials.gov ID
- NCT05861063
- Acronym / sponsor ID
- XijingH-PF-20232019-F-1
- Conditions
- Acne Atrophica
- Keywords
- Acne Scar, Dezocine, Pain Relief, Fractional CO2 Laser
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 11 Feb 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 May 2023 (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.
The Efficacy and Safety of Dezocine Pretreatment for Pain Relief in Acne Scar Treatment of Fractional CO2 Laser
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Device: Fractional CO2 laserThe patients were divided into 3 groups based on different dosages of Dezocine injection, with 35 patients in each group: Group 1: Dezocine low-dose group, Group 2: Dezocine high-dose group; Group 3: Blank control group (normal saline). |
| Dezocine low dose group | Experimental | Device: Fractional CO2 laser, Drug: DezocineThe patients were divided into 3 groups based on different dosages of Dezocine injection, with 35 patients in each group: Group 1: Dezocine low-dose group, Group 2: Dezocine high-dose group; Group 3: Blank control group (normal saline). |
| Dezocine high dose group | Experimental | Device: Fractional CO2 laser, Drug: DezocineThe patients were divided into 3 groups based on different dosages of Dezocine injection, with 35 patients in each group: Group 1: Dezocine low-dose group, Group 2: Dezocine high-dose group; Group 3: Blank control group (normal saline). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 18-60 years old, regardless of gender;
- Clinical diagnosis of atrophic acne scars;
- Planning to undergo ultra-pulsed CO2 lattice laser therapy;
- The patient agrees to participate in this experiment and signs an informed consent form
Key exclusion criteria (8 listed)
- Those who take sedative drugs for a long time;
- Patients with sleep apnea syndrome, previous history of hypertension, and blood pressure greater than 160/100mmHg
- People with severe heart and lung diseases, liver and kidney diseases, psychosis, pregnancy, and communication disorders;
- Persons who are known to be allergic to the main drug or any of the excipients in Dezocine injection;
- Increased intracranial pressure or head injury;
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 |
|---|---|---|
| Fractional CO2 laserAlso: paronosetron hydrochloride and lidocaine creamAll patients were given oral administration of 0.5mg paronosetron hydrochloride and lidocaine cream 1 hour before surgery. After cleaning and disinfection, fractional CO2 laser treatment was given. Among them, the fractional CO2 laser laser (American Medical Laser company) selected relatively constant energy parameters in the treatment | Device | Dezocine high dose group, Dezocine low dose group, control group |
| DezocineDesocine injection was injected intravenously half an hour before surgery (10ml normal saline was added for more than 30 seconds) | Drug | Dezocine high dose group, Dezocine low dose group |
Primary outcome
Visual Analog Score for Pain
Time frame: 24 hours
0 was classified as painless and 10 was classified as unbearable pain. Marks were made on the corresponding parts of the ruler and scores were scored according to the degree of patient's feeling
Hemodynamic parameters
Time frame: 24 hours
diastolic blood pressure (DBP), systolic blood pressure (SBP)
Heart rate (HR)
Time frame: 24 hours
Hemodynamic parameters
oxygen saturation (SpO2)
Time frame: 24 hours
Hemodynamic parameters
1 secondary outcome
Occurrence of Adverse Reactions
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: No
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.
Gang Wang, Prof principal investigator
Dermatology Derpartment of Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fractional CO2 laser and Dezocine in people with Acne Atrophica, run by Xijing Hospital 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 8 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 16 May 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Chen Yu, MD (13571991903 ext. 86, ycyc_2005@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Score for Pain (time frame: 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2023.