## Protocol Section
### Identification Module
**NCT ID:** NCT00877279

**Brief Title:** Multicenter Study of the Safety and Efficacy of Dermal Filler, Belotero® Soft

**Official Title:** A Randomized,Blinded,Controlled,Multicenter Study of the Safety and Effectiveness of Dermal Filler, Belotero® Soft, After Superficial to Mid Dermal Implantation for Correction of Mild Facial Wrinkles Over 4 Weeks.

#### Organization Study ID Info
**ID:** MUS 90028-0717/1
#### Organization
**Class:** INDUSTRY
**Full Name:** Merz North America, Inc.
### Status Module
#### Completion Date
**Date:** 2008-03

**Type:** ACTUAL

#### Disp First Post Date
**Date:** 2011-10-21

**Type:** ESTIMATED

**Disp First Submit Date:** 2011-10-12
**Disp First Submit QC Date:** 2011-10-12

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-11-15

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-10-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-03

**Type:** ACTUAL

#### Start Date
**Date:** 2007-11

**Status Verified Date:** 2013-10

#### Study First Post Date
**Date:** 2009-04-07
**Type:** ESTIMATED
**Study First Submit Date:** 2009-04-03
**Study First Submit QC Date:** 2009-04-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Merz North America, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study is to determine the safety and effectiveness of Belotero® Soft compared to active comparator in the correction of mild facial wrinkles, such as nasolabial folds.

**Detailed Description:** The purpose of the study is to see if Belotero® Soft is safe and effective for correction of mild facial wrinkles, such as nasolabial folds. The second objective of the study is to see if Belotero® Soft works better than the active comparator. Subjects will receive Belotero® Soft injection to one side of the face and the active comparator to the other side of the face.

### Conditions Module

**Conditions:**

- Facial Wrinkles

**Keywords:**

- Facial wrinkles

- Nasolabial folds

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 64

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Comparator will be given into the opposite side of the face that Belotero® Soft was administered for facial wrinkles, such as nasolabial folds.

**Intervention Names:**

- Device: Belotero Soft

**Label:** Belotero® Soft

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Device: CosmoDerm1

**Label:** CosmoDerm1

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- CosmoDerm1

**Description:** CosmoDerm1 is a single use syringe, injected into the mid dermal layer.

**Name:** CosmoDerm1

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Belotero® Soft

**Description:** Dermal Filler

**Name:** Belotero Soft

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** The severity of the facial wrinkle

**Time Frame:** 2 weeks and 4 weeks

#### Secondary Outcomes

**Measure:** Investigator and subject assessments

**Time Frame:** 2 weeks and 4 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Subjects must have bilateral facial wrinkles, such as nasolabial folds

Exclusion Criteria:

* Other nasolabial fold correction within 6 months prior to study entry.

**Healthy Volunteers:** True

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Los Angeles

**Country:** United States

**Facility:** Skin Care & Laser Physicians of Beverly Hills

**State:** California

**Zip:** 90069

**Location 2:**

**City:** San Francisco

**Country:** United States

**Facility:** Maas Clinic

**State:** California

**Zip:** 94115

**Location 3:**

**City:** New Haven

**Country:** United States

**Facility:** Savin Dermatology Center

**State:** Connecticut

**Zip:** 06511

**Location 4:**

**City:** Metairie

**Country:** United States

**Facility:** William Coleman, III, MD

**State:** Louisiana

**Zip:** 70006

**Location 5:**

**City:** White Plains

**Country:** United States

**Facility:** Dermatology Surgery and Laser Center

**State:** New York

**Zip:** 10604

#### Overall Officials

**Official 1:**

**Affiliation:** Dermatology Surgery and Laser Center

**Name:** Rhoda Narins, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M21089

- Name: Facies

- Relevance: HIGH

- As Found: Facial

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000019066

- Term: Facies

### Misc Info Module

- Version Holder: 2024-05-24
