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Gene Expression Changes In Young and Geriatric Skin

Plain-language guide to NCT03932162: early phase 1 non-randomized trial of IGF-1 LR3, 24 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03932162
Phase
early phase 1
Status
recruiting participants
Start
2019-09-06
Completion (planned or actual)
2025-12
Participants
24 (estimated)
Design
non-randomized, open label (everyone knows who gets what), prevention
Conditions studied
UVB Phototherapy Burn; Insulin-like Growth Factor 1; Aging
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this early phase 1 trial, researchers set out to test IGF-1 LR3.

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.

It had two arms (groups): Young Adult (placebo comparator) and Geriatric Adult (active comparator).

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

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.

The registry classes the interventions as drug and other.

Who Took Part

24 planned participants were the target.

It was open to people of any sex aged from 21 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: White skin (Fitzpatrick types I and II). Age 21-30 or 65 and older. Able to comprehend procedures/risks.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: known photosensitivity; currently on photosensitizing medications; diabetes mellitus.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

The IGF-1 LR3 group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label IGF-1 LR3 study: the participants and staff both knew the treatment.

It started in 2019-09-06 with completion listed for 2025-12.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Change in expression genes involved in protecting skin cells from UVB damage in younger skin and geriatric skin injected with IGF-1 from baseline (time frame: 2 Days).

What This Means in Plain Language

Put simply, this is a early phase 1, non-randomized trial of IGF-1 LR3 in 24 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the IGF-1 LR3 compound page, all human trials.

Our Notes on the Compound

IGF-1 LR3: A modified IGF-1 analog that escapes binding proteins, so it stays active ≥24 h.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.