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Alanyl Glutamine

Clinical trials are investigating Alanyl Glutamine in people with vulvar lichen sclerosus and chronic kidney disease-associated pruritus. These studies are checking whether the tested cream is effective and safe compared with a vehicle, which is the same cream without the active substance. The trials are in adults and use patient-reported itch scores as a main measure.

Table of contents

Clinical trials overview

Two interventional studies investigated Alanyl Glutamine in people with itching-related conditions.[1][2] Both trials were Phase 2 and both were marked as completed.[1][2]

The studies looked at whether the tested cream could help reduce itch compared with a cream base without the active substance, also called a vehicle.[1][2] The main focus was patient-reported itch relief over 12 weeks.[1][2]

Vulvar lichen sclerosus study

The trial titled Orchid 1 studied people with vulvar lichen sclerosus, a long-term skin condition that affects the vulvar area and can cause severe itching.[1] This study enrolled 40 participants and was done as a Phase 2 trial.[1]

Participants received either Alanyl Glutamine as a topical cream or a matching cream without the active substance.[1] The study was designed to explore efficacy, which means whether the treatment may help improve symptoms.[1]

The main endpoint was the mean change in weekly mean Worst Itch Numeric Rating Score (WI-NRS) from baseline to Week 12.[1] WI-NRS is a patient diary score used to measure how bad the itching feels.[1]

Chronic kidney disease-associated pruritus study

The second trial studied adults with chronic kidney disease-associated pruritus, which means itching linked to chronic kidney disease.[2] It enrolled 108 participants and was also a Phase 2 study.[2]

This study was a parallel-group, randomized, double-blind, 12-week trial.[2] Randomized means people were assigned by chance to a study group, and double-blind means neither the participants nor the researchers knew which treatment was given.[2]

Participants received either Alanyl Glutamine cutaneous use or a placebo-like cream that did not contain the active substance.[2] The study aimed to explore the clinical efficacy and safety of the cream compared with the vehicle.[2]

Study design and comparators

Both studies compared Alanyl Glutamine with a vehicle, which is the same cream without the active substance.[1][2] In the kidney disease study, the comparison product was also described as a placebo that did not contain the active substance.[2]

This type of design helps researchers see whether any change in itching is more likely due to the tested treatment rather than the cream base itself.[1][2] The 12-week study length gave enough time to measure symptom changes over time.[1][2]

Outcomes and endpoints

The main outcome in both trials was the change in Worst Itch Numeric Rating Score from the start of the study to Week 12.[1][2] This endpoint was recorded in the participant’s diary, making the patient’s own report of symptoms very important.[1][2]

In simple terms, the trials were asking whether people felt less itching after using the study cream for 12 weeks compared with the control cream.[1][2] The source data did not list other detailed endpoints, so the itch score is the key result described here.[1][2]

What participants were like

The trial data show that the studies focused on adults with a specific itching condition.[1][2] One group had vulvar lichen sclerosus, and the other group had chronic kidney disease-associated pruritus.[1][2]

These studies did not provide extra details about age ranges, sex limits, or other entry rules beyond the conditions studied.[1][2] What is clear is that the research was aimed at people whose main problem was persistent itch.[1][2]

Trial ID Phase Condition studied Status Enrollment
2023-503516-32-00 Phase 2 Vulvar lichen sclerosus (VLS) Completed 40
2022-500044-38-01 Phase 2 Chronic kidney disease-associated pruritus Completed 108

FAQ

  • What conditions are being studied in Alanyl Glutamine trials? The trials are studying vulvar lichen sclerosus and chronic kidney disease-associated pruritus. Both conditions involve troublesome itching, which is the main symptom being measured.
  • Who can take part in these trials? The studies enrolled adults with the target conditions. One trial focused on people with vulvar lichen sclerosus, and the other focused on adults with chronic kidney disease-associated pruritus.
  • What phase are the Alanyl Glutamine trials? Both studies are Phase 2 trials. Phase 2 trials look at early signs of benefit and continue to assess safety.
  • What is being compared in these studies? Alanyl Glutamine cream is being compared with a vehicle or placebo-like cream. The comparison helps show whether the active cream works better than the same cream without the active substance.
  • What outcome did the trials measure? The main outcome was the change in Worst Itch Numeric Rating Score, or WI-NRS, from the start of the study to Week 12. This score comes from the patient’s diary and measures how bad the itching feels.

Ongoing Clinical Trials on Alanyl Glutamine

  • Study on the Effectiveness and Safety of MC2-25 Cream for Women with Vulvar Lichen Sclerosus

    Not recruiting

    1
    Investigated drugs:
    Denmark

  • Study on the Effectiveness and Safety of MC2-25 Cream for Itching in Chronic Kidney Disease Patients

    Not recruiting

    1
    Investigated drugs:
    Germany Hungary Poland

Glossary

  • Vulvar lichen sclerosus (VLS): A long-term skin condition that affects the vulva, which is the outside part of the female genital area. It can cause itching and discomfort.
  • Chronic kidney disease-associated pruritus (CKD-aP): Itching that happens in people with chronic kidney disease. Pruritus means itch.
  • Pruritus: The medical word for itching.
  • Phase 2: A stage in clinical research that checks early signs of how well a treatment works and continues to look at safety.
  • Interventional study: A study where researchers give a treatment or compare treatments to see what happens.
  • Randomized: Participants are assigned by chance to different treatment groups.
  • Double-blind: A study design where the participants and researchers do not know which treatment the participant gets.
  • Vehicle: The cream base without the active substance. It is used to compare the real treatment against the same cream without the active ingredient.
  • Placebo: A comparison treatment that does not contain the active substance.
  • Worst Itch Numeric Rating Score (WI-NRS): A patient score that rates the worst itching felt over a time period, usually on a numeric scale.
  • Baseline: The starting point before treatment begins.
  • Week 12: The 12-week time point in the study, used to compare how symptoms changed over time.

References

  1. https://clinicaltrials.gov/study/2023-503516-32-00
  2. https://clinicaltrials.gov/study/2022-500044-38-01