Use of pneumatic needle-free hyaluronic acid injection technology for correction of atrophic facial acne scars in adult patients: a randomized placebo-controlled split-face comparative study.

JRCT ID: jRCTs052190078

Registered date:05/12/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: atrophic facial acne scars
• Date of first enrollment: 23/06/2020
• Target sample size: 33
• Study type: Interventional
• Intervention(s): The participant will be administered with hyaluronic acid solution by the EnerJet2.0 system (pneumatic needle-free injection technology) into individual facial scars by assigning one side of the face and the other side not to receive the treatments. The treatment course includes 3 treatment sessions conducted with a 4-week interval.

Outcome(s)

• Primary Outcome: Overall judgment of therapeutic efficacy
• Secondary Outcome: time-to-treatment-failure, adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 65age old
• Gender: Both
• Include criteria: Male or female 25-65 years old. Presence of more than 4 distensible facial moderate to severe atrophic acne scars.

Exclude criteria

Patient with having severe underlying disease, pregnancy or lactation, Porphyria, cardiac conduction disturbance, allergic conditioned, local anesthesia allergies and hyaluronic acid produced allergies previously, vascular or bleeding disorders, treated with anticoagulant therapy, autoimmune disease, treated with immunosuppressive therapy, keloid scar formation, hypertrophic scar formation, malignant skin tumor, pigment anomaly, inflammatory disease that a symptom may aggravate in irritation by a treatment, medical history of herpesvirus infection. Invasive aesthetic treatments or facial surgery within 6 months prior to the study enrollment.
Physical or chemical aesthetic treatments within 3 month prior to the study enrollment. Clinically significant acne in the proposed treatment areas defined as more than 3 active inflammatory acne lesions in the treatment areas.

Related Information

• Primary Sponsor: Yuki Yamamoto
• Secondary Sponsor: Chikako Kaminaka
• Source(s) of Monetary Support: JMEC Co., Ltd.