Trial Outcomes & Findings for Main Study: A Study to Evaluate the Effectiveness and Safety of GAL1906 for Correction of Wrinkles in the décolletage Area Sub-study: A Follow-up Study to Evaluate the Analysis of Mammograms Following Treatment for Correction of Wrinkles in Décolletage Area in the Investigational Study 43USRV1906 (NCT NCT04717934)

Last Updated: 2026-07-15

Results Overview

Responder was defined as participants having at least one grade improvement from baseline on the Galderma decolletage scale. Galderma Decolletage Scale was a validated 5-point scale used to assess the severity of lines and wrinkles in the décolletage area where: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (very severe). Higher scores indicated more severe lines and wrinkles in the décolletage area. Percentage of responders as assessed live by the blinded evaluator has been reported for this outcome measure. 95% confidence interval was calculated using Clopper-Pearson method.

Recruitment status

COMPLETED

Study phase

Target enrollment

211 participants

Primary outcome timeframe

At Week 12

Results posted on

2026-07-15

Participant Flow

This study was conducted at 14 investigational sites in the United States of America. The main study was conducted from 08 February 2021 to 20 September 2023, and the sub-study was conducted from 11 February 2025 to 13 June 2025.

A total of 245 participants were screened, of whom 34 failed screening and 211 were enrolled in the study. A total of 163 participants were treated with GAL1906 in the main study, of which, 66 participants who had evaluable images entered into the sub-study.

Participant milestones

Participant milestones
Measure	Main Study: GAL1906 Group Participants received a maximum of 3 milliliter (mL) injection of GAL1906 at baseline (Day 1), Week 4, and Week 8.	Main Study: No Treatment Group Participants did not receive any treatment.	Sub-study: No Treatment Participants who received GAL1906 in the main study and had mammogram data collected after their first GAL1906 treatment were included in the sub-study. Participants did not receive any treatment in sub-study.
Main Study (up to Week 56) STARTED	163	48	0
Main Study (up to Week 56) COMPLETED	149	44	0
Main Study (up to Week 56) NOT COMPLETED	14	4	0
Sub-Study(Up to12months after treatment) STARTED	0	0	66
Sub-Study(Up to12months after treatment) COMPLETED	0	0	66
Sub-Study(Up to12months after treatment) NOT COMPLETED	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Main Study: GAL1906 Group Participants received a maximum of 3 milliliter (mL) injection of GAL1906 at baseline (Day 1), Week 4, and Week 8.	Main Study: No Treatment Group Participants did not receive any treatment.	Sub-study: No Treatment Participants who received GAL1906 in the main study and had mammogram data collected after their first GAL1906 treatment were included in the sub-study. Participants did not receive any treatment in sub-study.
Main Study (up to Week 56) Withdrawal by Subject	9	3	0
Main Study (up to Week 56) Lost to Follow-up	5	1	0

Baseline Characteristics

Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: At Week 12

Population: Intent-to-treat (ITT) population Included all participants who were randomized and were analyzed according to the treatment they were randomized to.

Outcome measures

Outcome measures
Measure	GAL1906 Group n=144 Participants Participants received a maximum of 3 mL injection of GAL1906 at baseline (Day 1), Week 4, and Week 8.	No Treatment Group n=48 Participants Participants did not receive any treatment.
Percentage of Responders on the Galderma Decolletage Scale, as Assessed Live by the Blinded Evaluator, at Week 12	73.6 percentage of Participants Interval 65.6 to 80.6	18.8 percentage of Participants Interval 8.9 to 32.6

PRIMARY outcome

Timeframe: During treatment (anytime between Day 1 to Week 8 of main study), post first treatment on Day 1 and post last treatment (up to 12 months after receiving GAL1906 treatment in the Main study)

Population: The Sub-study Safety population included all participants who were treated with GAL1906 in the main study, agreed to participate in the sub-study, and had collection of mammographic data after first treatment with GAL1906. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "Number Analyzed" signifies participants in the specific rows.

The number of participants with interference in breast images obtained using any diagnostic image modality (such as mammogram, breast ultrasound, breast magnetic resonance imaging \[MRI\], biopsy, and other procedure)as determined by adjudicated radiologist is reported.

Outcome measures

Outcome measures
Measure	GAL1906 Group n=49 Participants Participants received a maximum of 3 mL injection of GAL1906 at baseline (Day 1), Week 4, and Week 8.	No Treatment Group Participants did not receive any treatment.
Sub-study: Number of Participants With Breast Image Interference, as Determined by Adjudicated Radiologist Post Last-Treatment Image	0 Participants	—
Sub-study: Number of Participants With Breast Image Interference, as Determined by Adjudicated Radiologist During Treatment Image	0 Participants	—
Sub-study: Number of Participants With Breast Image Interference, as Determined by Adjudicated Radiologist Post First-Treatment Image (Total)	0 Participants	—

Adverse Events

Main Study: GAL1906 Group

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Main Study: No Treatment Group

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Sub-study: No Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Main Study: GAL1906 Group n=163 participants at risk Participants received a maximum of 3 mL injection of GAL1906 at baseline, Week 4, and Week 8.	Main Study: No Treatment Group n=48 participants at risk Participants did not receive any treatment.	Sub-study: No Treatment Group n=66 participants at risk Participants who received GAL1906 in the main study and had mammogram data collected after their first GAL1906 treatment were included in the sub-study. Participants did not receive any treatment in sub-study.
Gastrointestinal disorders Food poisoning	0.61% 1/163 • Main study: From baseline (Day 1) up to Week 32 (no treatment group) and up to Week 56 (GAL1906 group) Sub-Study: Within 12 months after receiving last GAL1906 treatment in the Main study Safey population included all participants who treated with GAL1906 or randomized to no treatment Control Group. Participants analyzed according to the treatment actually received. Sub-study safety population included all participants who treated with GAL1906 in main study, agree to participate in sub-study, had collection of mammographic data after first treatment with GAL1906. MedDRA version 23.1 was used for data from main study and MedDRA version 25.0 was used when adding sub-study data.	0.00% 0/48 • Main study: From baseline (Day 1) up to Week 32 (no treatment group) and up to Week 56 (GAL1906 group) Sub-Study: Within 12 months after receiving last GAL1906 treatment in the Main study Safey population included all participants who treated with GAL1906 or randomized to no treatment Control Group. Participants analyzed according to the treatment actually received. Sub-study safety population included all participants who treated with GAL1906 in main study, agree to participate in sub-study, had collection of mammographic data after first treatment with GAL1906. MedDRA version 23.1 was used for data from main study and MedDRA version 25.0 was used when adding sub-study data.	0.00% 0/66 • Main study: From baseline (Day 1) up to Week 32 (no treatment group) and up to Week 56 (GAL1906 group) Sub-Study: Within 12 months after receiving last GAL1906 treatment in the Main study Safey population included all participants who treated with GAL1906 or randomized to no treatment Control Group. Participants analyzed according to the treatment actually received. Sub-study safety population included all participants who treated with GAL1906 in main study, agree to participate in sub-study, had collection of mammographic data after first treatment with GAL1906. MedDRA version 23.1 was used for data from main study and MedDRA version 25.0 was used when adding sub-study data.
Nervous system disorders Vertigo	0.61% 1/163 • Main study: From baseline (Day 1) up to Week 32 (no treatment group) and up to Week 56 (GAL1906 group) Sub-Study: Within 12 months after receiving last GAL1906 treatment in the Main study Safey population included all participants who treated with GAL1906 or randomized to no treatment Control Group. Participants analyzed according to the treatment actually received. Sub-study safety population included all participants who treated with GAL1906 in main study, agree to participate in sub-study, had collection of mammographic data after first treatment with GAL1906. MedDRA version 23.1 was used for data from main study and MedDRA version 25.0 was used when adding sub-study data.	0.00% 0/48 • Main study: From baseline (Day 1) up to Week 32 (no treatment group) and up to Week 56 (GAL1906 group) Sub-Study: Within 12 months after receiving last GAL1906 treatment in the Main study Safey population included all participants who treated with GAL1906 or randomized to no treatment Control Group. Participants analyzed according to the treatment actually received. Sub-study safety population included all participants who treated with GAL1906 in main study, agree to participate in sub-study, had collection of mammographic data after first treatment with GAL1906. MedDRA version 23.1 was used for data from main study and MedDRA version 25.0 was used when adding sub-study data.	0.00% 0/66 • Main study: From baseline (Day 1) up to Week 32 (no treatment group) and up to Week 56 (GAL1906 group) Sub-Study: Within 12 months after receiving last GAL1906 treatment in the Main study Safey population included all participants who treated with GAL1906 or randomized to no treatment Control Group. Participants analyzed according to the treatment actually received. Sub-study safety population included all participants who treated with GAL1906 in main study, agree to participate in sub-study, had collection of mammographic data after first treatment with GAL1906. MedDRA version 23.1 was used for data from main study and MedDRA version 25.0 was used when adding sub-study data.
Infections and infestations Mastoiditis	0.00% 0/163 • Main study: From baseline (Day 1) up to Week 32 (no treatment group) and up to Week 56 (GAL1906 group) Sub-Study: Within 12 months after receiving last GAL1906 treatment in the Main study Safey population included all participants who treated with GAL1906 or randomized to no treatment Control Group. Participants analyzed according to the treatment actually received. Sub-study safety population included all participants who treated with GAL1906 in main study, agree to participate in sub-study, had collection of mammographic data after first treatment with GAL1906. MedDRA version 23.1 was used for data from main study and MedDRA version 25.0 was used when adding sub-study data.	2.1% 1/48 • Main study: From baseline (Day 1) up to Week 32 (no treatment group) and up to Week 56 (GAL1906 group) Sub-Study: Within 12 months after receiving last GAL1906 treatment in the Main study Safey population included all participants who treated with GAL1906 or randomized to no treatment Control Group. Participants analyzed according to the treatment actually received. Sub-study safety population included all participants who treated with GAL1906 in main study, agree to participate in sub-study, had collection of mammographic data after first treatment with GAL1906. MedDRA version 23.1 was used for data from main study and MedDRA version 25.0 was used when adding sub-study data.	0.00% 0/66 • Main study: From baseline (Day 1) up to Week 32 (no treatment group) and up to Week 56 (GAL1906 group) Sub-Study: Within 12 months after receiving last GAL1906 treatment in the Main study Safey population included all participants who treated with GAL1906 or randomized to no treatment Control Group. Participants analyzed according to the treatment actually received. Sub-study safety population included all participants who treated with GAL1906 in main study, agree to participate in sub-study, had collection of mammographic data after first treatment with GAL1906. MedDRA version 23.1 was used for data from main study and MedDRA version 25.0 was used when adding sub-study data.

Other adverse events

Other adverse events
Measure	Main Study: GAL1906 Group n=163 participants at risk Participants received a maximum of 3 mL injection of GAL1906 at baseline, Week 4, and Week 8.	Main Study: No Treatment Group n=48 participants at risk Participants did not receive any treatment.	Sub-study: No Treatment Group n=66 participants at risk Participants who received GAL1906 in the main study and had mammogram data collected after their first GAL1906 treatment were included in the sub-study. Participants did not receive any treatment in sub-study.
Infections and infestations COVID-19	6.1% 10/163 • Main study: From baseline (Day 1) up to Week 32 (no treatment group) and up to Week 56 (GAL1906 group) Sub-Study: Within 12 months after receiving last GAL1906 treatment in the Main study Safey population included all participants who treated with GAL1906 or randomized to no treatment Control Group. Participants analyzed according to the treatment actually received. Sub-study safety population included all participants who treated with GAL1906 in main study, agree to participate in sub-study, had collection of mammographic data after first treatment with GAL1906. MedDRA version 23.1 was used for data from main study and MedDRA version 25.0 was used when adding sub-study data.	4.2% 2/48 • Main study: From baseline (Day 1) up to Week 32 (no treatment group) and up to Week 56 (GAL1906 group) Sub-Study: Within 12 months after receiving last GAL1906 treatment in the Main study Safey population included all participants who treated with GAL1906 or randomized to no treatment Control Group. Participants analyzed according to the treatment actually received. Sub-study safety population included all participants who treated with GAL1906 in main study, agree to participate in sub-study, had collection of mammographic data after first treatment with GAL1906. MedDRA version 23.1 was used for data from main study and MedDRA version 25.0 was used when adding sub-study data.	0.00% 0/66 • Main study: From baseline (Day 1) up to Week 32 (no treatment group) and up to Week 56 (GAL1906 group) Sub-Study: Within 12 months after receiving last GAL1906 treatment in the Main study Safey population included all participants who treated with GAL1906 or randomized to no treatment Control Group. Participants analyzed according to the treatment actually received. Sub-study safety population included all participants who treated with GAL1906 in main study, agree to participate in sub-study, had collection of mammographic data after first treatment with GAL1906. MedDRA version 23.1 was used for data from main study and MedDRA version 25.0 was used when adding sub-study data.

Additional Information

Galderma Clinical Project Manager

Galderma

Phone: +1 817-961-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Main Study: GAL1906 Group n=163 Participants Participants received a maximum of 3 mL injection of GAL1906 at baseline (Day 1), Week 4, and Week 8.	Main Study: No Treatment Group n=48 Participants Participants did not receive any treatment.	Sub- Study: No Treatment Group n=66 Participants Participants who received GAL1906 in the main study and had mammogram data collected after their first GAL1906 treatment were included in the sub-study. Participants did not receive any treatment in sub-study.	Total n=277 Participants Total of all reporting groups
Age, Continuous Main study	53.8 years STANDARD_DEVIATION 9.70 • n=163 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	52.1 years STANDARD_DEVIATION 8.28 • n=48 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	—	53.4 years STANDARD_DEVIATION 9.40 • n=211 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Age, Continuous Sub-study	—	—	57.2 years STANDARD_DEVIATION 8.57 • n=66 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	57.2 years STANDARD_DEVIATION 8.57 • n=66 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Sex: Female, Male Main study · Female	163 Participants n=163 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	48 Participants n=48 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	0 Participants Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	211 Participants n=211 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Sex: Female, Male Main study · Male	0 Participants n=163 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	0 Participants n=48 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	0 Participants Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	0 Participants n=211 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Sex: Female, Male Sub-study · Female	—	—	66 Participants n=66 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	66 Participants n=66 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Sex: Female, Male Sub-study · Male	—	—	0 Participants n=66 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	0 Participants n=66 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Ethnicity (NIH/OMB) Main study · Hispanic or Latino	30 Participants n=163 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	10 Participants n=48 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	—	40 Participants n=211 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Ethnicity (NIH/OMB) Main study · Not Hispanic or Latino	133 Participants n=163 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	38 Participants n=48 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	—	171 Participants n=211 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Ethnicity (NIH/OMB) Main study · Unknown or Not Reported	0 Participants n=163 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	0 Participants n=48 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	—	0 Participants n=211 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Ethnicity (NIH/OMB) Sub-study · Hispanic or Latino	—	—	17 Participants n=66 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	17 Participants n=66 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Ethnicity (NIH/OMB) Sub-study · Not Hispanic or Latino	—	—	49 Participants n=66 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	49 Participants n=66 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Ethnicity (NIH/OMB) Sub-study · Unknown or Not Reported	—	—	0 Participants n=66 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	0 Participants n=66 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Race/Ethnicity, Customized Main study · American Indian or Alaska Native	3 Participants n=163 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	1 Participants n=48 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	—	4 Participants n=211 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Race/Ethnicity, Customized Main study · Asian	1 Participants n=163 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	0 Participants n=48 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	—	1 Participants n=211 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Race/Ethnicity, Customized Main study · Native Hawaiian or Other Pacific Islander	0 Participants n=163 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	0 Participants n=48 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	—	0 Participants n=211 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Race/Ethnicity, Customized Main study · Black or African American	17 Participants n=163 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	0 Participants n=48 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	—	17 Participants n=211 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Race/Ethnicity, Customized Main study · White	137 Participants n=163 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	47 Participants n=48 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	—	184 Participants n=211 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Race/Ethnicity, Customized Main study · More than one race	2 Participants n=163 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	0 Participants n=48 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	—	2 Participants n=211 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Race/Ethnicity, Customized Main study · Other	3 Participants n=163 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	0 Participants n=48 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	—	3 Participants n=211 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Race/Ethnicity, Customized Sub-study · American Indian or Alaska Native	—	—	0 Participants n=66 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	0 Participants n=66 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Race/Ethnicity, Customized Sub-study · Asian	—	—	0 Participants n=66 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	0 Participants n=66 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Race/Ethnicity, Customized Sub-study · Native Hawaiian or Other Pacific Islander	—	—	0 Participants n=66 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	0 Participants n=66 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Race/Ethnicity, Customized Sub-study · Black or African American	—	—	6 Participants n=66 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	6 Participants n=66 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Race/Ethnicity, Customized Sub-study · White	—	—	57 Participants n=66 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	57 Participants n=66 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Race/Ethnicity, Customized Sub-study · More than one race	—	—	1 Participants n=66 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	1 Participants n=66 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Race/Ethnicity, Customized Sub-study · Other	—	—	2 Participants n=66 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.	2 Participants n=66 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.