NCT05861063

Brief Summary

The Efficacy and Safety of Dezocine Pretreatment for Pain Relief in Acne Scar Treatment of Fractional CO2 Laser

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
105

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2023

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

February 11, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 16, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 16, 2023

Status Verified

February 1, 2023

Enrollment Period

11 months

First QC Date

April 17, 2023

Last Update Submit

May 15, 2023

Conditions

Acne Atrophica

Keywords

Acne Scar, Dezocine, Pain Relief, Fractional CO2 Laser

Outcome Measures

Primary Outcomes (4)

  • 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

    24 hours

  • Hemodynamic parameters

    diastolic blood pressure (DBP), systolic blood pressure (SBP)

    24 hours

  • Heart rate (HR)

    Hemodynamic parameters

    24 hours

  • oxygen saturation (SpO2)

    Hemodynamic parameters

    24 hours

Secondary Outcomes (1)

  • Occurrence of Adverse Reactions

    24 hours

Study Arms (3)

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).

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).

Device: Fractional CO2 laserDrug: 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).

Device: Fractional CO2 laserDrug: Dezocine

Interventions

Fractional CO2 laserDEVICE

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

Also known as: paronosetron hydrochloride and lidocaine cream
Dezocine high dose groupDezocine low dose groupcontrol group
DezocineDRUG

Desocine injection was injected intravenously half an hour before surgery (10ml normal saline was added for more than 30 seconds)

Dezocine high dose groupDezocine low dose group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dermatology Derpartment of Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Interventions

dezocine

Study Officials

  • Gang Wang, Prof

    Dermatology Derpartment of Xijing Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen Yu, MD

CONTACT

13571991903ycyc_2005@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2023

First Posted

May 16, 2023

Study Start

February 11, 2023

Primary Completion

December 30, 2023

Study Completion

December 31, 2024

Last Updated

May 16, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)