Clinical Study to Evaluate the Efficacy and Safety of Dermalax(Deep) in Correction of Nasolabial Folds

NCT ID: NCT02179619

Last Updated: 2014-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-02-28

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.

Conditions

Correction of Nasolabial Folds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dermalax(Deep)

subject injected in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period

Group Type: EXPERIMENTAL

Dermalax(Deep)

Intervention Type: DEVICE

Dermalax(Deep) injection into one nasolabial fold (NLF) of one side of the face (blinded, split-face study design) in the Initial Treatment period

Restylane

Intervention Type: DEVICE

Restylane Injection into one nasolabial fold (NLF) of one side of the face (blinded, split-face study design) in the Initial Treatment period

Restylane

Subject injected in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period

Group Type: ACTIVE_COMPARATOR

Dermalax(Deep)

Intervention Type: DEVICE

Dermalax(Deep) injection into one nasolabial fold (NLF) of one side of the face (blinded, split-face study design) in the Initial Treatment period

Restylane

Intervention Type: DEVICE

Restylane Injection into one nasolabial fold (NLF) of one side of the face (blinded, split-face study design) in the Initial Treatment period

Interventions

Dermalax(Deep)

Dermalax(Deep) injection into one nasolabial fold (NLF) of one side of the face (blinded, split-face study design) in the Initial Treatment period

Intervention Type: DEVICE

Restylane

Restylane Injection into one nasolabial fold (NLF) of one side of the face (blinded, split-face study design) in the Initial Treatment period

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Across Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beom Joon Kim, PhD

Role: PRINCIPAL_INVESTIGATOR

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Jong Hoon Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

Eulji General Hospital

Locations

Chung-ang University Hospital

Seoul, , South Korea

Eulji General Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

HG-HADNSF-12103

Identifier Type: -

Identifier Source: org_study_id