A study of efficacy and safety of pneumatic needleless micro-jet injector for the treatment of striae distensae
Not Applicable
Recruiting
- Conditions
- abdominal striae distensae
- Registration Number
- TCTR20171223001
- Lead Sponsor
- Division of Dermatology, Department of Medicine, Faculty of Medicine, Mahidol University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
1. age of 18 years or older
2. having stable striae distensae on lower abdominal area without change for at least 6 months
3. willing to return for every required follow-up visits
4. capacity to giving written informed consent
Exclusion Criteria
1. pregnancy and lactation
2. history of allergy to hyaluronic acid, fillers, or local anesthesia
3. having topical drugs, injectables, devices, or surgery 1 year prior to recruitment
4. history of tanning within 1 month
5. history of connective tissue disease or keloid
6. having infection, dermatitis, skin cancer, or abnormal skin condition in treatment area
7. immunocompromised host
8. taking isotretinoin 1 year prior to recruitment
9. unable to follow the protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Physician assesment week 0, 4, 8, 20, 32 visual analog scale of color, texture, degree of atrophy
- Secondary Outcome Measures
Name Time Method Histopathological assessment week 0, 8 evaluation of dermal collagen and elastin