Insulin-Like Growth Factor 1 for Aging Skin

Recruiting in Palo Alto (17 mi)

Overseen by Jeffrey B Travers, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Wright State University

Must not be taking: Photosensitizing medications

Disqualifiers: Photosensitivity, Diabetes, Abnormal scarring, others

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study does not involve any particular diagnosis. The goal of this research study is to explore the effects of artificial sunlight (ultraviolet B radiation; UVB) on the skin of young adults versus geriatric adults. Sunlight exerts many effects on the body. There is evidence that in response to ultraviolet B radiation (UVB), which are the burning rays of sunlight, young adult skin responds differently than geriatric skin. In fact, researchers feel that this difference in how the skin reacts to UVB is why skin cancers are found in older skin. Researchers believe that a major difference between young adult and geriatric skin is that young skin has a lot of a protein called insulin-like growth factor-1 (IGF-1), whereas geriatric skin has very little. The current study will test how young adult versus geriatric skin responds to UVB, and if geriatric skin treated with an injection of small amount of IGF-1 drug will then act like young skin.

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).

What evidence supports the effectiveness of the treatment Insulin-Like Growth Factor 1 (IGF-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 increase IGF-1 levels in the skin have been shown to reduce the risk of skin damage and cancer, indicating potential benefits for aging skin. ^{1 2 3 4 5}

Is Insulin-Like Growth Factor 1 (IGF-1) safe for use in humans?

IGF-1 has been used in clinical trials for conditions like Laron syndrome and diabetes, and adverse effects seem to be related to taking too much. Some studies have shown that both growth hormone and IGF-1 can cause significant health issues, especially in elderly people. ^{1 6 7 8 9}

How does the drug IGF-1 differ from other treatments for aging skin?

IGF-1 (Insulin-Like Growth Factor 1) is unique because it is a hormone similar to insulin that helps with tissue regeneration and growth, which may benefit aging skin by promoting cell repair and renewal. Unlike other treatments, IGF-1 works by binding to specific receptors in the skin, potentially offering a novel approach to addressing age-related skin changes. ^{1 10 11 12 13}

Research Team

Jeffrey B Travers, MD, PhD

Principal Investigator

Wright State University

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Insulin-Like Growth Factor 1 (Protein Drug)
• No Insulin-Like Growth Factor 1 (Other)

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.

Participant Groups

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.

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

References

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

Insulin-like growth factors and aging. [2018]

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

Diverse roles of growth hormone and insulin-like growth factor-1 in mammalian aging: progress and controversies. [2021]

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

Interplay of IGF-I and 17beta-estradiol at age-specific levels in human sebocytes and fibroblasts in vitro. [2013]

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

Randomized controlled trial of fractionated laser resurfacing on aged skin as prophylaxis against actinic neoplasia. [2023]

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

Plasma IGF-I levels and cognitive performance in older women. [2016]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of human growth hormone on body composition in elderly men. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Carpal tunnel syndrome and gynaecomastia during growth hormone treatment of elderly men with low circulating IGF-I concentrations. [2019]

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

Functional consequences of the somatopause and its treatment. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical use of somatomedin-1: yes or no? [2018]

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

Serum insulin-like growth factor-1 in centenarians: implications of IGF-1 as a rapid turnover protein. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Clinical relevance of insulin-like growth factor-1 to cardiovascular risk markers. [2022]

12. Poland 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]. [2006]

13. New Zealand pubmed.ncbi.nlm.nih.gov

Insulin-Like growth factor I: implications in aging. [2018]