Back to resultsTreatment of Acne Vulgaris Using NAFL in Combination With Isotretinoin and Pricking Blood Therapy
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
1,565nm NAFL
Oral isotretinoin
Pricking blood therapy
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne vulgaris, Acne scars, 1,565 nm non-ablative fractional laser, Isotretinoin, pricking blood therapy
Eligibility Criteria
Inclusion Criteria:
- Patients ranged in age from twenty to forty years old
- Clinically diagnosed as a facial acne patient
- The patients meet the needs of the research program of this topic
Exclusion Criteria:
- pregnancy
- liver or kidney functional abnormality
- skin ulceration with active bacteria
- fungal or viral infection or skin cancer
- coagulation disorders
- patients on drugs of agents
- systemic diseases such as cardiovascular disease
- epilepsy
- diabetes
- immunodeficiency disease
- active psoriasis
Sites / Locations
- Dermatology Derpartment of Xijing Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Experimental
Arm Label
1,565nm NAFL only group
Oral isotretinoin only group
Double therapy group
Triple therapy group
Arm Description
Patients were first treated by the 1,565nm M22-ResurFx NAFL on inflammatory papules and boxcar atrophic scars using round or rectangle light spots with similar sizes of individual lesional papules or scars. The energy fluence was 60 mJ and spot density was 150 spots/cm2. A whole face pass treatment was followed using hexagon or rectangle light spots with fluences of 40-45 mJ, density of 200 spots/cm2 and no overlap on light spots. The end points of the treatment were appearance of localized erythema, edema and bruise on treated areas. A facial sheet mask (skin repair dressing, Panion & BF Biotech Inc, Zhuhai, China) was used to clean the face after laser treatment, and the face was cooled by air cooler for 10 minutes. The patients received three treatment sessions with a 6-week interval between each session.
Subjects received oral isotretinoin (Xingyi Yan'an Pharmaceutical, Shanghai, China) (1mg/kg/d for the first 2-4 weeks and 0.5mg/kg/d for the next 12-14 weeks) for a total of 16 weeks. Serum triglycerides, cholesterol and levels of liver enzymes were monitored every month during oral isotretinoin medication.
The patients first received 2-4 weeks of oral isotretinoin medication (1mg/kg/d), followed by 1565nm M22-ResurFx NAFL treatment. Subjects were then given isotretinoin with a dosage of 0.5 mg/kg/d for the next 12-14 weeks. Laser treatment parameters and procedures were as same as in the group one above.
The patients received the same treatments as the subjects in group (3) with additional PBT. At the end point of each session of laser treatment, an acupuncture practitioner performed a PBT in the areas within 1.5 cm radius of the five facial acupoints (Yintang, Zhukong, Sun, Yingxiang, Cuanzhu) (Figure 1). These areas usually appeared intensive erythema. A facial sheet mask was used to clean the face after PBT, and the face was cooled by air cooler for 10 minutes.
Outcomes
Primary Outcome Measures
Visia CR imaging system
With fast capture times and lighting modes designed to enhance the visualization
Antera3D® system
The indexes of facial skin texture and other datas were quantitatively measured by the Antera3D® system before and after treatments.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04156815
Brief Title
Treatment of Acne Vulgaris Using NAFL in Combination With Isotretinoin and Pricking Blood Therapy
Official Title
Treatment of Acne Vulgaris Using 1,565 nm Non-ablative Fractional Laser in Combination With Isotretinoin and Pricking Blood Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
July 5, 2018 (Actual)
Primary Completion Date
October 5, 2018 (Actual)
Study Completion Date
October 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
xjpfW
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
BACKGROUND Isotretinoin remains one of the first line medications for moderate-to-severe acne vulgaris (AV) but its side effect is a major concern for Asian patients.
OBJECTIVE Investigators aimed to evaluate the efficacy and safety of the 1,565 nm non-ablative fractional laser (NAFL) in combination with isotretinoin and pricking blood therapy (PBT) for treatment of AV.
METHODS A retrospective analysis of 60 patients with moderate-to-severe AV was performed. Four groups (n=15) were evaluated: 1,565nm NAFL alone, oral isotretinoin alone, double therapy (NAFL + isotretinoin) and triple therapy (NAFL + isotretinoin + PBT).
Detailed Description
BACKGROUND Isotretinoin remains one of the first line medications for moderate-to-severe acne vulgaris (AV) but its side effect is a major concern for Asian patients.
OBJECTIVE Investigators aimed to evaluate the efficacy and safety of the 1,565 nm non-ablative fractional laser (NAFL) in combination with isotretinoin and pricking blood therapy (PBT) for treatment of AV.
METHODS A retrospective analysis of 60 patients with moderate-to-severe AV was performed. Four groups (n=15) were evaluated: 1,565nm NAFL alone, oral isotretinoin alone, double therapy (1,565 nm non-ablative fractional laser + isotretinoin) and triple therapy (1,565 nm non-ablative fractional laser+ isotretinoin + PBT).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne vulgaris, Acne scars, 1,565 nm non-ablative fractional laser, Isotretinoin, pricking blood therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1,565nm NAFL only group
Arm Type
Active Comparator
Arm Description
Patients were first treated by the 1,565nm M22-ResurFx NAFL on inflammatory papules and boxcar atrophic scars using round or rectangle light spots with similar sizes of individual lesional papules or scars. The energy fluence was 60 mJ and spot density was 150 spots/cm2. A whole face pass treatment was followed using hexagon or rectangle light spots with fluences of 40-45 mJ, density of 200 spots/cm2 and no overlap on light spots. The end points of the treatment were appearance of localized erythema, edema and bruise on treated areas. A facial sheet mask (skin repair dressing, Panion & BF Biotech Inc, Zhuhai, China) was used to clean the face after laser treatment, and the face was cooled by air cooler for 10 minutes. The patients received three treatment sessions with a 6-week interval between each session.
Arm Title
Oral isotretinoin only group
Arm Type
Active Comparator
Arm Description
Subjects received oral isotretinoin (Xingyi Yan'an Pharmaceutical, Shanghai, China) (1mg/kg/d for the first 2-4 weeks and 0.5mg/kg/d for the next 12-14 weeks) for a total of 16 weeks. Serum triglycerides, cholesterol and levels of liver enzymes were monitored every month during oral isotretinoin medication.
Arm Title
Double therapy group
Arm Type
Active Comparator
Arm Description
The patients first received 2-4 weeks of oral isotretinoin medication (1mg/kg/d), followed by 1565nm M22-ResurFx NAFL treatment. Subjects were then given isotretinoin with a dosage of 0.5 mg/kg/d for the next 12-14 weeks. Laser treatment parameters and procedures were as same as in the group one above.
Arm Title
Triple therapy group
Arm Type
Experimental
Arm Description
The patients received the same treatments as the subjects in group (3) with additional PBT. At the end point of each session of laser treatment, an acupuncture practitioner performed a PBT in the areas within 1.5 cm radius of the five facial acupoints (Yintang, Zhukong, Sun, Yingxiang, Cuanzhu) (Figure 1). These areas usually appeared intensive erythema. A facial sheet mask was used to clean the face after PBT, and the face was cooled by air cooler for 10 minutes.
Intervention Type
Radiation
Intervention Name(s)
1,565nm NAFL
Intervention Description
1,565nm M22-ResurFx NAFL can deliver additional benefits to existing acne scar and skin texture. Patients were first treated by the 1,565nm M22-ResurFx NAFL on inflammatory papules and boxcar atrophic scars using round or rectangle light spots with similar sizes of individual lesional papules or scars. The energy fluence was 60 mJ and spot density was 150 spots/cm2. A whole face pass treatment was followed using hexagon or rectangle light spots with fluences of 40-45 mJ, density of 200 spots/cm2 and no overlap on light spots. The end points of the treatment were appearance of localized erythema, edema and bruise on treated areas.
Intervention Type
Drug
Intervention Name(s)
Oral isotretinoin
Intervention Description
Oral isotretinoin has remained the most effective medication for moderate-to-severe AV.Subjects received oral isotretinoin (Xingyi Yan'an Pharmaceutical, Shanghai, China) (1mg/kg/d for the first 2-4 weeks and 0.5mg/kg/d for the next 12-14 weeks) for a total of 16 weeks. Serum triglycerides, cholesterol and levels of liver enzymes were monitored every month during oral isotretinoin medication.
Intervention Type
Other
Intervention Name(s)
Pricking blood therapy
Intervention Description
Pricking blood therapy (PBT) is a modified acupuncture strategy that is adapted to treat inflammatory related diseases. It has been shown to be effective in treatment of many chronic and acute inflammatory conditions including vasomotor rhinitis, acute herpes zoster and acute gouty arthritis,suggesting a potential efficacy for AV as well. At the end point of each session of laser treatment, an acupuncture practitioner performed a PBT in the areas within 1.5 cm radius of the five facial acupoints (Yintang, Zhukong, Sun, Yingxiang, Cuanzhu) (Figure 1). These areas usually appeared intensive erythema. A facial sheet mask was used to clean the face after PBT, and the face was cooled by air cooler for 10 minutes.
Primary Outcome Measure Information:
Title
Visia CR imaging system
Description
With fast capture times and lighting modes designed to enhance the visualization
Time Frame
change from week0 to week24
Title
Antera3D® system
Description
The indexes of facial skin texture and other datas were quantitatively measured by the Antera3D® system before and after treatments.
Time Frame
change from week0 to week24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients ranged in age from twenty to forty years old
Clinically diagnosed as a facial acne patient
The patients meet the needs of the research program of this topic
Exclusion Criteria:
pregnancy
liver or kidney functional abnormality
skin ulceration with active bacteria
fungal or viral infection or skin cancer
coagulation disorders
patients on drugs of agents
systemic diseases such as cardiovascular disease
epilepsy
diabetes
immunodeficiency disease
active psoriasis
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of Acne Vulgaris Using NAFL in Combination With Isotretinoin and Pricking Blood Therapy
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