GAL1906 for Wrinkles

Recruiting at10 trial locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Q-Med AB

Must not be taking: Injectable HA gel

Disqualifiers: Allergy to lidocaine, Pregnant, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment called GAL1906 to see if it can safely and effectively reduce wrinkles in the upper chest area. It focuses on people who want to improve the appearance of their skin in that region.

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 data supports the effectiveness of the treatment GAL1906 for wrinkles?

The effectiveness of GAL1906 for wrinkles may be supported by research on similar treatments, such as a serum containing epidermal growth factor (EGF) that improved fine lines and skin texture, and Argireline, which reduced wrinkle depth by 48.9% in a study. These findings suggest that treatments targeting skin rejuvenation can be effective in reducing wrinkles. ^{1 2 3 4 5}

How does the treatment GAL1906 for wrinkles differ from other treatments?

GAL1906 is unique because it may involve components like low-molecular-weight collagen peptides, which have been shown to improve skin elasticity, hydration, and reduce wrinkles when taken orally. This approach differs from topical treatments by working from the inside out to enhance skin properties. ^{3 6 7 8 9}

Research Team

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• GAL1906 (Other)

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.

Participant Groups

Group I: GAL1906 Experimental Treatment 1 Intervention

Experimental product for correction of wrinkles

Group II: 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

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2015]

2. England 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. [2019]

3. England pubmed.ncbi.nlm.nih.gov

The anti wrinkle efficacy of synthetic hexapeptide (Argireline) in Chinese Subjects. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Collagen injection therapy in elderly women: long-term results and patient satisfaction. [2019]

5. England pubmed.ncbi.nlm.nih.gov

A potential relationship between skin hydration and stamp-type microneedle intradermal hyaluronic acid injection in middle-aged male face. [2022]

6. United States 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. [2022]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Effect of red ginseng NaturalGEL on skin aging. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Oral intake of specific bioactive collagen peptides reduces skin wrinkles and increases dermal matrix synthesis. [2016]

9. England pubmed.ncbi.nlm.nih.gov

Longitudinal study of skin aging: from microrelief to wrinkles. [2011]