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se 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.

Phase 3
Conditions
atrophic facial acne scars
atrophic scar
D001284
Registration Number
JPRN-jRCTs052190078
Lead Sponsor
Yuki Yamamoto
Brief Summary

The findings of this study suggest that PA-HA treatment is effective against all severity rolling type atrophic facial acne scars in Japanese subjects and has minimal AEs.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
30
Inclusion Criteria

Male or female 25-65 years old. Presence of more than 4 distensible facial moderate to severe atrophic acne scars.

Exclusion 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Overall judgment of therapeutic efficacy
Secondary Outcome Measures
NameTimeMethod
time-to-treatment-failure, adverse events
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