Treatment of Acne Vulgaris Using NAFL in Combination With Isotretinoin and Pricking Blood Therapy

NCT ID: NCT04156815

Last Updated: 2019-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-05
• Study Completion Date: 2018-10-05

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).

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

1,565nm NAFL

Intervention Type: RADIATION

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 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.

Group Type: ACTIVE_COMPARATOR

Oral isotretinoin

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

1,565nm NAFL

Intervention Type: RADIATION

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

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

1,565nm NAFL

Intervention Type: RADIATION

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

Intervention Type: DRUG

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

Intervention Type: OTHER

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.

Interventions

1,565nm NAFL

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: RADIATION

Oral isotretinoin

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: DRUG

Pricking blood therapy

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

xjpfW

OTHER

Sponsor Role: lead

Responsible Party

xjpfW

Head of Dermatology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gang Wang, Prof

Role: PRINCIPAL_INVESTIGATOR

Dermatology Derpartment of Xijing Hospital

Locations

Dermatology Derpartment of Xijing Hospital

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

xjpfW

Identifier Type: -

Identifier Source: org_study_id