Clinical trial NCT02179619: Clinical Study to Evaluate the Efficacy and Safety of Dermalax(Deep) in Correction of Nasolabial Folds
Official title: A Randomized, Multi-center, Patient & Evaluator-blind, Matched Pairs, Active-controlled Design Clinical Study to Evaluate the Efficacy and Safety of Injection With Dermalax(Deep) as Compared to Restylane® in Correction of Nasolabial Fold
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Correction of Nasolabial Folds
Lead sponsor: Across Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-07-02
Enrollment: 66
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is to verify that Dermalax (Deep) is not inferior to the reference device, Restylane®, in terms of efficacy and safety in the correction of nasolabial folds. Subjects who voluntarily signed the informed consent and are judged to be eligible for this study will be intradermally injected both of study device and comparator device. Subjects will be randomized to receive injection of study device and comparator device on their each nasolabial fold. Efficacy is evaluated based on the change in Wrinkle Severity Rating Scale (WSRS) from baseline. Safety will be assessed based on 24 weeks follow up visits and subject diary which will be given to subjects during the first 2 weeks after the injection. Any uncomfortable things and adverse events will be investigated from subject diary and follow up visits.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects no younger than 30 and no more than 65 years of age.
2. Subjects who scored 3 or 4 on the Wrinkle Severity Rating Scale (WSRS) and want to improve the appearance of their nasolabial folds (the subject does not need to have the same score on both sides.\*)

   \*The scores need not to be same on both sides, but the two nasolabial folds should have symmetry in the range of 3-4.
3. Subjects who have symmetric nasolabial folds.
4. Subjects who agreed to discontinue the use of any dermatological procedure or therapy, including facial wrinkle reduction procedures.
5. Subjects with the ability to understand and follow the instructions and who are committed to availability for the entire study period.
6. Subjects who have voluntarily decided to participate in this study and who have signed the informed consent form.

Exclusion Criteria:

1. Subjects who show hypersensitive skin reaction to the investigational devices, confirmed by the intradermal reaction test performed at screening.
2. Subjects who received an antithrombotic agent within 2 weeks prior to screening (with the exception of low dose Aspirin 100 mg, maximum of 300 mg/day) or NSAIDs or Vitamin E within 1 week.
3. Subjects with a liver problem and/or blood coagulation defect or subjects who require the administration of an antithrombotic agent during the clinical trial period (with the exception of low dose Aspirin 100 mg, maximum of 300 mg/day).
4. Subjects who have used a local ointment on their faces (medication such as steroid or retinoid are included and cosmetic products are excluded from this criterion) within 4 weeks prior to screening or subjects who are planning on using such an ointment during the clinical trial period.
5. Subjects who have received treatment for wrinkles or acne within 24 weeks prior to screening.
6. Subjects who have received facial (chemical) peels and/or skin rejuvenation procedures or plastic surgeries, including the injection of the Botulinum toxin, within 24 weeks prior to screening.
7. Subjects who have a permanent skin expander such as soft form or silicon implanted in the face.
8. Subjects who have scars on the face requiring a medical treatment but who have not received any treatment for more than a year or subjects who have scars or wounds on which the test investigational devices will be applied.
9. Subjects with skin disease or wound infection on the face.

Primary outcomes:
measure: Wrinkle Severity Rating Scale(WSRS) evaluation
timeFrame: at week 24
Secondary outcomes:
measure: The mean of the WSRS scores from both the Dermalax (Deep) group and the Restylane® group
timeFrame: at week 8~ 48
measure: The mean of the WSRS scores from both the Dermalax (Deep) group and the Restylane® group
timeFrame: at week 8~ 48
measure: The mean of the Global Aesthetic Improvement Scale(GAIS) scores from both the Dermalax (Deep) group and the Restylane® group
timeFrame: at week 8~48
measure: Mean of the Global Aesthetic Improvement Scale(GAIS) scores from both the Dermalax (Deep) group and the Restylane® group
timeFrame: at week 8~48
measure: The proportion of subjects whose WSRS scores decreased at least 1 level
timeFrame: at week 0~48
measure: The proportion of subjects whose WSRS scores decreased at least 1 level
timeFrame: at week 0~48
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Eulji General Hospital
Study officials:
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Beom Joon Kim, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Eulji General Hospital
name: Jong Hoon Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References: