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

Acne Vulgaris Clinical Trial

Official title:

Treatment of Acne Vulgaris Using 1,565 nm Non-ablative Fractional Laser in Combination With Isotretinoin and Pricking Blood Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04156815
• Other study ID #: xjpfW
• Status: Completed
• Phase: N/A
• Start date: July 5, 2018
• Est. completion date: October 5, 2018

Study information

• Verified date: November 2019
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 5, 2018
• Est. primary completion date: October 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Radiation:
• 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.

Drug:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
China	Dermatology Derpartment of Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
xjpfW

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visia CR imaging system	With fast capture times and lighting modes designed to enhance the visualization	change from week0 to week24
Primary	Antera3D® system	The indexes of facial skin texture and other datas were quantitatively measured by the Antera3D® system before and after treatments.	change from week0 to week24