In short
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.
Key points
- Clinical trials of Alanyl Glutamine are studying itching-related conditions in adults. One Phase 2 study looked at vulvar lichen sclerosus, and another Phase 2 study looked at chronic kidney disease-associated pruritus. Both trials compared an active cream with a vehicle or placebo-like cream without the active substance. The main outcome in both studies was change in the Worst Itch Numeric Rating Score over 12 weeks. Both trials were completed.
Clinical trials overview
Two interventional studies investigated Alanyl Glutamine in people with itching-related conditions. Both trials were Phase 2 and both were marked as completed.
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. The main focus was patient-reported itch relief over 12 weeks.
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. This study enrolled 40 participants and was done as a Phase 2 trial.
Participants received either Alanyl Glutamine as a topical cream or a matching cream without the active substance. The study was designed to explore efficacy, which means whether the treatment may help improve symptoms.
The main endpoint was the mean change in weekly mean Worst Itch Numeric Rating Score (WI-NRS) from baseline to Week 12. WI-NRS is a patient diary score used to measure how bad the itching feels.
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. It enrolled 108 participants and was also a Phase 2 study.
This study was a parallel-group, randomized, double-blind, 12-week trial. 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.
Participants received either Alanyl Glutamine cutaneous use or a placebo-like cream that did not contain the active substance. The study aimed to explore the clinical efficacy and safety of the cream compared with the vehicle.
Study design and comparators
Both studies compared Alanyl Glutamine with a vehicle, which is the same cream without the active substance. In the kidney disease study, the comparison product was also described as a placebo that did not contain the active substance.
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. The 12-week study length gave enough time to measure symptom changes over time.
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. This endpoint was recorded in the participant’s diary, making the patient’s own report of symptoms very important.
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. The source data did not list other detailed endpoints, so the itch score is the key result described here.
What participants were like
The trial data show that the studies focused on adults with a specific itching condition. One group had vulvar lichen sclerosus, and the other group had chronic kidney disease-associated pruritus.
These studies did not provide extra details about age ranges, sex limits, or other entry rules beyond the conditions studied. What is clear is that the research was aimed at people whose main problem was persistent itch.