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

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Status: Completed

Conditions: Acne Vulgaris

Treatments: Drug: Oral isotretinoin; Radiation: 1,565nm NAFL; Other: Pricking blood therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04156815

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Details and patient eligibility

About

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).

Full 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).

Enrollment: 60 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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60 participants in 4 patient groups

1,565nm NAFL only group

Active Comparator group

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.

Treatment:

Radiation: 1,565nm NAFL

Oral isotretinoin only group

Active Comparator group

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.

Treatment:

Drug: Oral isotretinoin

Double therapy group

Active Comparator group

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.

Treatment:

Drug: Oral isotretinoin

Radiation: 1,565nm NAFL

Triple therapy group

Experimental group

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.

Treatment:

Drug: Oral isotretinoin

Radiation: 1,565nm NAFL

Other: Pricking blood therapy