Insulin-Like Growth Factor 1 for Aging Skin

Overseen By Regulatory Specialist

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Wright State University

Must not be taking: Photosensitizing medications

Disqualifiers: Photosensitivity, Diabetes, Abnormal scarring, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 2 days

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how skin of different ages reacts to artificial sunlight, specifically UVB rays, which cause sunburn. Researchers aim to determine if older skin, typically lower in a protein called insulin-like growth factor-1 (IGF-1), can react like younger skin when treated with IGF-1. Participants will either receive UVB treatment alone or an IGF-1 injection followed by UVB exposure. Individuals with naturally white skin, who are either young adults or seniors and can understand the study's procedures, may be suitable for this trial. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking scientific discovery.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on photosensitizing medications (drugs that make your skin more sensitive to sunlight).

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that a protein called Insulin-Like Growth Factor 1 (IGF-1) plays a crucial role in maintaining healthy skin, particularly as people age. Some studies have found that older skin with lower IGF-1 levels often experiences more issues, suggesting that adding IGF-1 might enhance skin health.

Past studies provide limited information about safety. This trial is in its early stages, so there is not yet much evidence on how well participants tolerate the treatment. Early trials primarily focus on understanding safety and the body's reaction to the treatment.

If IGF-1 has approval for other uses, it might suggest some level of safety, but this does not guarantee its safety for skin treatments. Researchers are still learning about its safety in this specific area. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard anti-aging treatments that mostly involve topical creams or laser therapies, the investigational use of Insulin-Like Growth Factor 1 (IGF-1) for aging skin introduces a novel approach. IGF-1 is unique because it targets cellular regeneration directly by promoting skin cell growth and repair, potentially reversing signs of aging at a deeper, cellular level. This approach is different from existing options, which primarily focus on surface-level improvements. Researchers are excited about IGF-1 because it offers the promise of a more profound and long-lasting impact on skin rejuvenation, potentially leading to healthier skin from the inside out.

What evidence suggests that Insulin-Like Growth Factor 1 might be an effective treatment for aging skin?

Research has shown that Insulin-Like Growth Factor 1 (IGF-1) plays a crucial role in skin aging. Studies have found that IGF-1 promotes skin cell growth and increases skin thickness. This is significant because aging skin typically has reduced IGF-1 levels, which may contribute to aging signs. IGF-1 also helps maintain cell health and prevents premature aging. In this trial, some participants will receive IGF-1 injections to evaluate its effects on aging skin. Early evidence suggests that boosting IGF-1 levels in older skin might help it respond to sunlight more like young skin. ^{1 2 6 7 8}

Who Is on the Research Team?

Jeffrey B Travers, MD, PhD

Principal Investigator

Wright State University

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 21-30 or 65 and older with white skin (Fitzpatrick types I and II). Participants must understand the procedures and risks. Those with allergies to lidocaine, serious health issues, on photosensitizing meds, diabetes, abnormal scarring history, skin infections, pregnancy/nursing or known photosensitivity cannot join.

Inclusion Criteria

I understand the procedures and risks involved.

I am either between 21-30 years old or 65 and older.

I am either male or female.

Exclusion Criteria

You are known to have a sensitivity to light.

You have a history of scars that are not normal.

I am taking medication that increases my sensitivity to light.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Young adult skin is treated with UVB, and geriatric skin is injected with IGF-1 or saline and then treated with UVB

2 days

1 visit (in-person)

Follow-up

Participants are monitored for changes in gene expression related to UVB damage protection

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Insulin-Like Growth Factor 1
• No Insulin-Like Growth Factor 1

Trial Overview The study investigates how young adult versus geriatric skin responds to artificial sunlight (UVB). It will test if treating geriatric skin with an injection of IGF-1 makes it respond like young skin. The intervention includes exposure to UVB and possibly receiving an IGF-1 injection.

How Is the Trial Designed?

Group I: Geriatric Adult Active Control 1 Intervention

Four small areas will undergo injection of a small amount of IGF-1 drug and two will undergo injections with saline. Then the injected areas will be treated with a small amount of UVB.

Group II: Young Adult Placebo Group 1 Intervention

One small area of skin will undergo treatment with a small amount of UVB.

No Insulin-Like Growth Factor 1 is already approved in United States, European Union for the following indications:

Approved in United States as IGF-1 for:

• Growth hormone deficiency
• Short stature

Approved in European Union as Somatomedin C for:

• Growth hormone deficiency
• Short stature

Who Is Running the Clinical Trial?

Wright State University

Lead Sponsor

Trials

47

Recruited

55,300+

Jeffrey B. Travers, MD, PhD

Lead Sponsor

Trials

5

Recruited

160+

Published Research Related to This Trial

Recombinant human IGF-I (somatomedin-1) is effective as a replacement therapy for conditions like Laron syndrome, promoting growth and increasing muscle and bone mass while normalizing blood chemistry.

Somatomedin-1 also enhances insulin sensitivity and glucose utilization in both types of diabetes, and may aid in healing nerve tissue and improving kidney function, although adverse effects are linked to overdosing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical use of somatomedin-1: yes or no? Laron, Z.[2018]

The decline in the GHRH-GH-IGF axis, known as somatopause, is linked to negative effects of aging, leading to interest in hormone replacement therapy for elderly individuals.

While some studies show that growth hormone (GH) and insulin-like growth factor (IGF-I) can improve body composition and quality of life, there are also reports of only minor benefits and potential significant health risks associated with their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional consequences of the somatopause and its treatment. Hoffman, AR., Lieberman, SA., Butterfield, G., et al.[2022]

The somatomedin hypothesis suggests that the growth-promoting effects of growth hormone are primarily mediated by insulin-like growth factors (IGFs), particularly IGF I and IGF II, which interact with specific receptors on target cells.

Circulating levels of IGF I increase during childhood and peak in adolescence, contributing to growth, but decline with age, potentially linked to decreased growth hormone secretion; however, definitive proof of its role in aging-related anabolic changes is still lacking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin-like growth factors and aging. Hammerman, MR.[2018]

In a study of 590 women aged 60-68, higher levels of the IGF-I/IGFBP-3 molar ratio were linked to better performance in general cognitive tests, suggesting a potential role of IGF-I in cognitive aging.

The improvement in cognitive performance associated with higher IGF-I levels was comparable to the cognitive differences observed between women just one year apart in age, highlighting its significance in cognitive health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasma IGF-I levels and cognitive performance in older women. Okereke, O., Kang, JH., Ma, J., et al.[2016]

In a study of 45 men over 61 years old, those treated with biosynthetic human growth hormone (hGH) showed an increase in plasma somatomedin C levels, which is linked to improved lean body mass and reduced adipose mass over a 21-month period.

The treatment aimed to counteract the natural decline in growth hormone secretion associated with aging, suggesting that hGH could help mitigate age-related body composition changes, such as muscle atrophy and increased fat accumulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of human growth hormone on body composition in elderly men. Rudman, D., Feller, AG., Cohn, L., et al.[2018]

Growth hormone and insulin-like growth factor-1 (IGF-1) levels decrease with age, and their roles in healthy aging are complex, showing both beneficial and harmful effects depending on the context.

The chapter suggests that rather than viewing the effects of these hormones as simply positive or negative, we should investigate their specific roles at different life stages to better understand their impact on aging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diverse roles of growth hormone and insulin-like growth factor-1 in mammalian aging: progress and controversies. Sonntag, WE., Csiszar, A., deCabo, R., et al.[2021]

Insulin-like growth factor-I (IGF-I) is crucial for lipid synthesis in human sebocytes and significantly stimulates fibroblast proliferation, indicating its key role in skin aging.

In contrast, hormones like 17beta-estradiol, progesterone, and dehydroepiandrosterone did not directly affect lipid synthesis or sebocyte proliferation, suggesting their effects may occur through indirect pathways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interplay of IGF-I and 17beta-estradiol at age-specific levels in human sebocytes and fibroblasts in vitro. Makrantonaki, E., Vogel, K., Fimmel, S., et al.[2013]

A single treatment of fractionated laser resurfacing (FLR) significantly reduced the occurrence of actinic keratosis (AK) and nonmelanoma skin cancers (NMSC) in older adults, with only 2 NMSCs developing in the treated arm compared to 24 in the untreated arm over 36 months.

FLR effectively restored the skin's response to UVB exposure by eliminating senescent fibroblasts, suggesting it could be a promising preventive treatment for aging populations at high risk for skin cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of fractionated laser resurfacing on aged skin as prophylaxis against actinic neoplasia. Spandau, DF., Chen, R., Wargo, JJ., et al.[2023]

In a study of 83 elderly men with low IGF-I levels, treatment with human growth hormone (hGH) significantly increased lean body mass and reduced adipose mass, with the most favorable results seen when IGF-I levels were maintained between 0.5-1.0 units/ml.

However, higher IGF-I levels above 1.0 units/ml were associated with increased side effects, such as carpal tunnel syndrome and gynaecomastia, suggesting that careful monitoring of IGF-I levels during hGH treatment is crucial to minimize adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carpal tunnel syndrome and gynaecomastia during growth hormone treatment of elderly men with low circulating IGF-I concentrations. Cohn, L., Feller, AG., Draper, MW., et al.[2019]

In a study of 49 centenarians, low serum IGF-1 levels were found, confirming that IGF-1 declines with age even in individuals at extreme old age, indicating a potential marker for aging.

The research revealed a strong association between low IGF-1 levels and higher prevalence of dementia, suggesting that IGF-1 may play a role in cognitive decline among the elderly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serum insulin-like growth factor-1 in centenarians: implications of IGF-1 as a rapid turnover protein. Arai, Y., Hirose, N., Yamamura, K., et al.[2019]

In a study of 427 patients with an average age of 52.8 years, lower serum IGF-1 levels were linked to higher levels of inflammatory markers, indicating a potential role of IGF-1 in inflammation and cardiovascular health.

The research suggests that declining IGF-1 levels with age may increase the risk of cardiovascular events, making serum IGF-1 a significant marker for assessing cardiovascular risk, especially in males.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical relevance of insulin-like growth factor-1 to cardiovascular risk markers. Harada, K., Hanayama, Y., Obika, M., et al.[2022]

Insulin-like growth factor 1 (IGF-1) plays a crucial role in growth regulation and tissue regeneration, acting both systemically and locally in the body, particularly after binding to its receptors.

The complex formation of IGF-1 with binding proteins regulates its availability and activity, which is important for diagnosing and treating various conditions, including pituitary diseases and complications related to diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Insulin-like growth factor 1 (somatomedin C) and its binding proteins 1 and 3 in children with special consideration of diabetes]. Niedźwiedzka, A.[2006]

Circulating levels of insulin-like growth factor (IGF)-I are influenced by growth hormone (GH) and show significant age-related changes, increasing during puberty and decreasing in the elderly due to various factors including impaired hormone secretion and nutritional deficiencies.

The decline in IGF-I levels in older adults may contribute to age-related changes in multiple body systems, but it remains uncertain whether supplementing with exogenous IGF-I can effectively reverse these changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin-Like growth factor I: implications in aging. Arvat, E., Broglio, F., Ghigo, E.[2018]

Citations

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The GH/IGF-1 axis in ageing and longevity - PubMed Central Deficiency of insulin-like growth factor 1 reduces sensitivity to aging-associated cardiomyocyte dysfunction. Rejuvenation Res. 2008;11:725 ...

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Impact of Age and Insulin-Like Growth Factor-1 on DNA ... In this review, we highlight studies that have considered age as a variable in examining DNA damage responses in UV-irradiated skin.

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Insulin-Like Growth Factor 1 for Aging Skin Research suggests that IGF-1 plays a key role in skin aging, as it can stimulate skin cell growth and improve skin thickness. Additionally, treatments that ...

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Insulin‐Like Growth Factor I Prevents Cellular Aging via ... Our data suggest that activation of IGF-1 signaling is a novel potential strategy to activate mitophagy and slow cellular aging.

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The IGF-1/IGF-1R signaling axis in the skin: a new role for ... We demonstrate that the silencing of IGF-1 expression in geriatric dermis results in the enhanced development of initiated keratinocytes in geriatric skin.

7. frontiersin.org frontiersin.org/journals/aging/articles/10.3389/fragi.2025.1549453/full

Growth hormone and aging: a clinical review This review examines the molecular mechanisms of GH in aging, its potential as an anti-aging therapy, and findings from clinical trials involving these ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1040842813000310

The key role of growth hormone–insulin–IGF-1 signaling in ... Further work established that the insulin/IGF-like signaling (IIS) pathway controls aging in worms, insects and mammals, and those homologies of the genes ...