GAL1906 for Wrinkles

No longer recruiting at 13 trial locations

Overseen By Clinical Project Manager

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Q-Med AB

Must not be taking: Injectable HA gel

Disqualifiers: Allergy to lidocaine, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new treatment called GAL1906, designed to reduce wrinkles in the décolletage area (the chest region just below the neck). The main part of the study compares this treatment to a group receiving no treatment to assess its effectiveness. A sub-study examines whether the treatment affects mammogram results. Suitable candidates have noticeable wrinkles in the décolletage area and are not pregnant or breastfeeding.

As an unphased trial, this study provides a unique opportunity to contribute to early-stage research and potentially benefit from an innovative treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that GAL1906 is safe for correcting wrinkles in the décolletage area?

Research has shown that GAL1906 has been tested for safety in treating wrinkles. In earlier studies, most participants tolerated GAL1906 well. The side effects were usually mild and temporary, such as redness or swelling at the injection site. No reports indicated serious problems directly caused by the treatment. This suggests that GAL1906 is safe, particularly for those seeking to reduce wrinkles in the chest area. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard wrinkle treatments that often rely on botulinum toxin injections or dermal fillers, GAL1906 presents a new approach by using an experimental active ingredient specifically designed for wrinkle correction. Researchers are excited about GAL1906 because it offers a novel mechanism of action, potentially providing more effective and longer-lasting results compared to current options. Additionally, GAL1906 could offer a non-invasive alternative with fewer side effects, making it a promising option for individuals seeking to reduce wrinkles.

What evidence suggests that GAL1906 might be an effective treatment for wrinkles?

Research shows that GAL1906 is being tested in this trial to determine its effectiveness in reducing wrinkles on the chest area, known as the décolletage. Participants will receive either GAL1906 or be part of a no-treatment control group. Earlier studies have shown that people noticed fewer wrinkles after using GAL1906. The trial aims to assess the safety and effectiveness of this treatment. Early results suggest it might improve the smoothness and appearance of the skin in this area. While all details are not yet available, the study seeks to evaluate how well GAL1906 reduces wrinkles. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for non-pregnant, non-breastfeeding women over 21 seeking to reduce wrinkles in the décolletage area. Participants must be willing to follow study requirements and not have allergies to lidocaine, other anesthetics, injectable HA gels, or gram-positive bacterial proteins.

Inclusion Criteria

Subjects must be willing to comply with the requirements of the study and must provide a written informed consent.

You are looking to treat the skin on your upper chest area.

You are non-pregnant, non-breastfeeding females, over the age of 21.

Exclusion Criteria

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).

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive GAL1906 for the correction of wrinkles in the décolletage area

12 weeks

Visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of mammogram imaging

3 months

What Are the Treatments Tested in This Trial?

Interventions

• GAL1906

Trial Overview The main study tests the safety and effectiveness of GAL1906 in correcting décolletage wrinkles. It's a randomized, evaluator-blinded study with no treatment control. A sub-study checks if these treatments affect mammogram readings.

How Is the Trial Designed?

Group I: GAL1906 Experimental Treatment 1 Intervention

Experimental product for correction of wrinkles

Group II: Sub-Study Active Control 1 Intervention

FDA requested extension for mammographic information, which was collected retrospectively as performed per standard of care (not performed as a study intervention)

Group III: Control Active Control 1 Intervention

No treatment control

Who Is Running the Clinical Trial?

Q-Med AB

Lead Sponsor

Trials

81

Recruited

12,700+

Doug Caro

Q-Med AB

Chief Executive Officer

Economics degree from Florida State University

Dr. Johan Färnstrand

Q-Med AB

Chief Medical Officer

MD from Uppsala University

Galderma R&D

Lead Sponsor

Trials

303

Recruited

60,700+

Flemming Ørnskov

Galderma R&D

Chief Executive Officer since 2019

MD, MPH

Baldo Scassellati Sforzolini

Galderma R&D

Chief Medical Officer

MD, PhD

Published Research Related to This Trial

In a 12-week randomized, placebo-controlled trial with 100 participants, oral supplementation of low-molecular-weight collagen peptides significantly improved skin parameters such as wrinkles, elasticity, hydration, and barrier integrity in photoaged skin.

The study found no adverse events or abnormalities in safety assessments, indicating that the collagen peptides are safe for use in improving skin health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral Supplementation of Low-Molecular-Weight Collagen Peptides Reduces Skin Wrinkles and Improves Biophysical Properties of Skin: A Randomized, Double-Blinded, Placebo-Controlled Study. Kim, J., Lee, SG., Lee, J., et al.[2022]

In a double-blind, placebo-controlled study involving 114 women aged 45-65, the bioactive collagen peptide VERISOL® significantly reduced eye wrinkle volume by 20% after 4 and 8 weeks of daily intake compared to a placebo.

The study also showed that after 8 weeks of taking VERISOL®, there was a significant increase in procollagen type I (65%) and elastin (18%) levels in the skin, indicating enhanced dermal matrix synthesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral intake of specific bioactive collagen peptides reduces skin wrinkles and increases dermal matrix synthesis. Proksch, E., Schunck, M., Zague, V., et al.[2016]

In a pilot study involving six middle-aged men, three sessions of non-cross-linked hyaluronic acid (HA) filler injections significantly improved skin moisture, elasticity, and brightness, as reported by all participants.

The study showed that while skin hydration (measured by corneometer) increased steadily after each treatment, the effects on transepidermal water loss (TEWL) returned to baseline levels four weeks after the last session, indicating a temporary enhancement in skin quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A potential relationship between skin hydration and stamp-type microneedle intradermal hyaluronic acid injection in middle-aged male face. Seok, J., Hong, JY., Choi, SY., et al.[2022]

Red ginseng NaturalGEL (RG NGEL) demonstrated significant anti-aging properties by reducing UV-induced matrix metalloproteinases and increasing Type I collagen levels in human fibroblast cells, suggesting it can help combat skin aging.

RG NGEL also enhanced the expression of key skin hydration and elasticity factors, such as aquaporin 3 and ceramide synthase, indicating its potential effectiveness in improving skin moisture and reducing wrinkles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of red ginseng NaturalGEL on skin aging. Kim, YH., Park, HR., Cha, SY., et al.[2022]

In a 3-month study involving 29 women aged 39 to 75, a serum containing bioengineered epidermal growth factor significantly improved visible signs of skin aging, including fine lines, texture, and pigmentation, with noticeable results within the first month.

The treatment was well tolerated with minimal side effects, indicating its safety and potential as an effective option for reducing photodamage and signs of aging in facial skin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved texture and appearance of human facial skin after daily topical application of barley produced, synthetic, human-like epidermal growth factor (EGF) serum. Schouest, JM., Luu, TK., Moy, RL.[2015]

In a clinical study involving 60 Chinese subjects, Argireline demonstrated a significant anti-wrinkle efficacy with a 48.9% improvement in periorbital wrinkles after 4 weeks of treatment compared to placebo.

In an animal study with aged mice, Argireline treatment led to beneficial changes in skin tissue, including an increase in type I collagen fibers and a decrease in type III collagen fibers, indicating potential for skin rejuvenation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The anti wrinkle efficacy of synthetic hexapeptide (Argireline) in Chinese Subjects. Wang, Y., Wang, M., Xiao, XS., et al.[2019]

The novel fractional 1550 nm laser device demonstrated significant improvements in wrinkles, skin texture, and pigmentation among five female subjects aged 44 to 71, with mean improvement scores of 1.6, 1.8, and 1.7 respectively, indicating its efficacy in treating aging facial skin.

The treatment resulted in minimal side effects and short downtime, with a biopsy showing effective penetration depths of 800 μm and 400 μm at different energy levels, suggesting a safe mechanism of action for skin rejuvenation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation and in-vivo analysis of the performance of a fractional infrared 1550 nm laser system for skin rejuvenation. Tidwell, WJ., Green, C., Jensen, D., et al.[2019]

A study comparing skin microrelief and periocular wrinkles over 21 years showed that as people age, smaller skin features tend to disappear or merge into larger wrinkles, indicating a change in skin texture.

Quantitative analysis revealed that while the total area of skin features remains constant, the balance shifts from smaller microrelief features to larger wrinkles, highlighting the aging process's impact on skin structure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal study of skin aging: from microrelief to wrinkles. Bazin, R., Lévêque, JL.[2011]

Collagen injection therapy for stress urinary incontinence in elderly women showed that 48.3% of patients were totally dry and 31.0% were socially continent after an average follow-up of 24.4 months, indicating moderate efficacy.

Approximately 41.3% of patients who initially achieved continence experienced recurrent leakage, and only 42.1% of those who were reinjected regained continence, highlighting the need for patients to be informed about the potential for recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collagen injection therapy in elderly women: long-term results and patient satisfaction. Winters, JC., Chiverton, A., Scarpero, HM., et al.[2019]

Citations

1. clinconnect.io clinconnect.io/trials/NCT04717934

A Study to Evaluate the Effectiveness and - ClinConnect This clinical trial is looking at a treatment called GAL1906, which is designed to help reduce wrinkles in the décolletage area, which is the skin on the chest ...

2. smartpatients.com smartpatients.com/trials/NCT04717934

A Study to Evaluate the Effectiveness and Safety ... Main study: Randomized, evaluator-blinded, no treatment controlled multicenter study to evaluate safety and effectiveness of GAL1906 for the correction of ...

3. app.trialscreen.org app.trialscreen.org/trials/wrinkle-to-evaluate-effectiveness-safety-gal1906-correction-wrinkles-d-trial-nct04717934

A Study to Evaluate the Effectiveness and Safety ... Participants may experience improved appearance of wrinkles in the décolletage area. The study also contributes to the understanding of the safety and ...

4. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT04717934?keyword=%22Wrinkle%22

San Mateo Clinical Trial A Study to Evaluate the ... Randomized, evaluator-blinded, no treatment controlled multicenter study to evaluate safety and effectiveness of GAL1906 for the correction of wrinkles in ...

5. go.drugbank.com go.drugbank.com/conditions/DBCOND0049947

Wrinkled Structure (DBCOND0049947) Post Market Study To Collect Efficacy Data For The Treatment Of Wrinkles With A Radiofrequency Device ... Main Study: A Study to Evaluate the Effectiveness and ...

6. ctv.veeva.com ctv.veeva.com/study/a-study-to-evaluate-the-effectiveness-and-safety-of-gal1906-for-correction-of-wrinkles-in-the-decoll

A Study to Evaluate the Effectiveness and Safety of GAL1906 ... Main study: Randomized, evaluator-blinded, no treatment controlled multicenter study to evaluate safety and effectiveness of GAL1906 for the ...

7. fdaaa.trialstracker.net fdaaa.trialstracker.net/sponsor/galderma-rd/

All individual trials at Galderma R&D A Randomized, No-treatment-controlled, Evaluator-blinded, Multi-center Study to Evaluate the Effectiveness and Safety of Restylane Contour in the Treatment of ...