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NCT Number: NCT04156815

Treatment of Acne Vulgaris Using NAFL 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).

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dermatology Derpartment of Xijing Hospital

Xi'an, Shaanxi, 710032, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1,565nm NAFL

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

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

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.

Primary outcomes

  1. Visia CR imaging system

    Time frame: change from week0 to week24

    With fast capture times and lighting modes designed to enhance the visualization

  2. Antera3D® system

    Time frame: change from week0 to week24

    The indexes of facial skin texture and other datas were quantitatively measured by the Antera3D® system before and after treatments.

Sponsors and collaborators

Lead sponsor

xjpfW

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 8, 2019
Registry last updated
Nov 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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