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

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Primary Purpose

Status

Recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Fractional CO2 laser

Dezocine

About this trial

This is an interventional supportive care trial for Acne Atrophica focused on measuring Acne Scar, Dezocine, Pain Relief, Fractional CO2 Laser

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 -

Sites / Locations

Dermatology Derpartment of Xijing HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

control group

Dezocine low dose group

Dezocine high dose group

Arm Description

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).

Outcomes

Primary Outcome Measures

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

Hemodynamic parameters

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

Heart rate (HR)

Hemodynamic parameters

oxygen saturation (SpO2)

Hemodynamic parameters

Secondary Outcome Measures

Occurrence of Adverse Reactions

Nausea, vomiting，dizziness，respiratory depression

Full Information

NCT ID

NCT05861063

First Posted

April 17, 2023

Last Updated

May 15, 2023

Sponsor

Xijing Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05861063

Brief Title

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

Official Title

The Efficacy and Safety of Dezocine Pretreatment for Pain Relief in Acne Scar

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 11, 2023 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Atrophica

Keywords

Acne Scar, Dezocine, Pain Relief, Fractional CO2 Laser

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

control group

Arm Type

Placebo Comparator

Arm Description

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).

Arm Title

Dezocine low dose group

Arm Type

Experimental

Arm Description

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).

Arm Title

Dezocine high dose group

Arm Type

Experimental

Arm Description

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).

Intervention Type

Device

Intervention Name(s)

Fractional CO2 laser

Other Intervention Name(s)

paronosetron hydrochloride and lidocaine cream

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Dezocine

Intervention Description

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

Primary Outcome Measure Information:

Title

Visual Analog Score for Pain

Description

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

Time Frame

24 hours

Title

Hemodynamic parameters

Description

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

Time Frame

24 hours

Title

Heart rate (HR)

Description

Hemodynamic parameters

Time Frame

24 hours

Title

oxygen saturation (SpO2)

Description

Hemodynamic parameters

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Occurrence of Adverse Reactions

Description

Nausea, vomiting，dizziness，respiratory depression

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chen Yu, MD

Phone

13571991903

Ext

86

Email

ycyc_2005@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gang Wang, Prof

Organizational Affiliation

Dermatology Derpartment of Xijing Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dermatology Derpartment of Xijing Hospital

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gang Wang, prof

Phone

+8684775401

Email

xjwgang@fmmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

No

Acne Atrophica

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial