A Study to Evaluate the Effectiveness and Safety of GAL1906 for Correction of Wrinkles in the décolletage Area

• Sponsor: Galderma R&D (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04717934
• Collaborator: (none)
• Enrollment: 192
• Locations: 14
• Arms: 2
• Anticipated Duration (Months): 31.1
• Patients Per Site: 13.7
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

Randomized, evaluator-blinded, no treatment controlled multicenter study to evaluate safety and effectiveness of GAL1906 for the correction of wrinkles in the décolletage area.

Condition or Disease	Intervention/Treatment	Phase
Wrinkle	Device: GAL1906	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 192 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Evaluator-blinded, No-treatment Controlled, Multicenter Study to Evaluate the Effectiveness and Safety of GAL1906 for Correction of Wrinkles in the décolletage Area
• Actual Study Start Date: Jan 27, 2021
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GAL1906	Device: GAL1906; hyaluronic acid dermal filler gel
No Intervention: Control

Outcome Measures

Primary Outcome Measures

1. The percentage of responders on the Galderma Décolletage Scale, as assessed live by the Blinded Evaluator, at Week 12. [12 weeks after initial injection]

   Responder defined as at least one grade improvement from baseline

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects willing to comply with the requirements of the study and providing a signed written informed consent.

• Non-pregnant, non-breastfeeding females, over the age of 21.

• Subjects seeking treatment for the décolletage.

Exclusion Criteria:

• Known/previous allergy or hypersensitivity to any injectable HA gel or to gram positive bacterial proteins.

• History of allergy or hypersensitivity to lidocaine or other amidetype anesthetics, or topical anesthetics or nerve blocking agents (if such products are intended to be used for that subject).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Galderma Research Site	Birmingham	Alabama	United States	35209
2	Galderma Research Site	Scottsdale	Arizona	United States	85255
3	Galderma Research Site	Redondo Beach	California	United States	90277
4	Galderma Research Site	San Diego	California	United States	92121
5	Galderma Research Site	Vista	California	United States	92083
6	Galderma Research Site	Westport	Connecticut	United States	06880
7	Galderma Research Site	Boynton Beach	Florida	United States	33472
8	Galderma Research Site	Coral Gables	Florida	United States	33146
9	Galderma Research Site	Alpharetta	Georgia	United States	30022
10	Galderma Research Site	Chicago	Illinois	United States	60654
11	Galderma Research Site	Baltimore	Maryland	United States	21208
12	Galderma Research Site	New York	New York	United States	10021
13	Galderma Research Site	Spring	Texas	United States	77388
14	Galderma Research Site	Mequon	Wisconsin	United States	53092

Sponsors and Collaborators

• Galderma R&D

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT04717934
• Other Study ID Numbers: 43USRV1906
• First Posted: Jan 22, 2021
• Last Update Posted: May 11, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Galderma R&D: Wrinkles in the Décolletage Area

Study Results

No Results Posted as of May 11, 2022