- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04156815
Treatment of Acne Vulgaris Using NAFL in Combination With Isotretinoin and Pricking Blood Therapy
Treatment of Acne Vulgaris Using 1,565 nm Non-ablative Fractional Laser in Combination With Isotretinoin and Pricking Blood Therapy
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).
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Shaanxi
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Xi'an, Shaanxi, China, 710032
- Dermatology Derpartment of Xijing Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1,565nm NAFL only group
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.
|
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.
|
Active Comparator: Oral isotretinoin only group
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.
|
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.
|
Active Comparator: Double therapy group
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.
|
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.
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.
|
Experimental: Triple therapy group
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.
|
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visia CR imaging system
Time Frame: change from week0 to week24
|
With fast capture times and lighting modes designed to enhance the visualization
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change from week0 to week24
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Antera3D® system
Time Frame: change from week0 to week24
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The indexes of facial skin texture and other datas were quantitatively measured by the Antera3D® system before and after treatments.
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change from week0 to week24
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gang Wang, Prof, Dermatology Derpartment of Xijing Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- xjpfW
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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