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CARBOMER 980

Carbomer 980 is a gel-forming ingredient that has been studied in different clinical trial products, including a nasal spray tested for common cold symptoms and safety, and a topical “vehicle” gel used as a comparison in an itch study. Clinical trials with carbomer 980 mainly look at how well people tolerate it (for example, how the nasal lining looks after repeated use) and how symptoms are measured during treatment.

Table of Contents

What Carbomer 980 is in these trials

Carbomer 980 was used as a gel ingredient in trial products, including a nasal spray gel (1146A) and a topical vehicle gel used for comparison in an itch study.[1][2][3]

In a European trial record, carbomer 980 is described as a substance of polymer origin and is listed as a “gelling agent” (meaning it helps form a gel texture).[4]

Where Carbomer 980 was used (nasal spray, topical vehicle gel, listed product)

In common cold research, carbomer 980 was part of a test nasal spray gel product referred to as 1146A (carbomer 980 nasal spray gel).[1][2]

In a pruritus (itch) proof-of-concept study, carbomer 980 was listed as the drug name for the topical vehicle gel, meaning it was the comparison gel base (not the active itch-relief drug).[3]

In a separate European trial record (Turner syndrome), carbomer 980 appears as a medicinal product entry named “CARBOMER 980” with pharmaceutical form “EYE GEL,” and it is also labeled as a “gelling agent,” with route listed as transdermal use in that product entry.[4]

Common cold: efficacy study of 1146A (Carbomer 980) nasal spray

A multi-center study in adults with symptoms of the common cold evaluated whether 1146A nasal spray could reduce symptom severity compared with placebo, and it also evaluated safety.[2]

The study design was randomized, parallel-group, placebo-controlled, and double-blind.[2]

Participants in the carbomer 980 (1146A) group used a nasal spray containing carbomer 980 gel, given as three actuations per nostril per dose, with each actuation 140 microliters (equivalent to 140 mg).[2]

The placebo group used a reference nasal spray vehicle without carbomer 980, also given as three actuations per nostril per dose, with each actuation 140 microliters.[2]

Healthy adults: local nasal tolerability and safety study of 1146A

A single-center study in healthy adults assessed the local nasal tolerability and safety of multiple intranasal administrations of 1146A delivered by a nasal spray applicator.[1]

The study design was randomized, parallel-group, placebo-controlled, with an outcomes assessor masked (meaning the person judging outcomes was kept unaware of group assignment).[1]

In the test group, participants received a nasal spray containing 0.5% carbomer 980, 4 times per day, with 3 actuations per nostril per dose and 140 microliters (140 mg) per actuation.[1]

In the placebo comparator group, participants received a vehicle nasal spray without carbomer 980 on the same schedule and actuation volume.[1]

Pruritus (itch): Carbomer 980 as the vehicle gel in a topical acetaminophen study

A proof-of-concept study in healthy subjects tested topical acetaminophen gels for itch relief and compared them to a vehicle gel.[3]

The study was described as single-blinded, vehicle-controlled, and randomized, with each subject testing three acetaminophen concentrations and one vehicle treatment across two visits (one for histaminergic itch and one for non-histaminergic itch).[3]

In this trial record, the vehicle comparator arm lists “Drug: Carbomer 980,” and the drug listing describes carbomer 980 as the topical vehicle gel (the gel base).[3]

The gels were applied to a predefined 4×4 cm area on the ventral forearm, allowed to absorb for 30 minutes, then residual gel was removed before itch induction and sensory testing in that area.[3]

How outcomes were measured (symptom scores and grading scales)

In the common cold efficacy study, the primary outcome was Average Nasal Symptom Score (ANSS) over days 1–4.[2]

The nasal symptom score was the sum of runny nose, blocked nose, and sneezing, with each symptom self-rated from 0 (absent) to 3 (severe), for a total range of 0–9.[2]

The ANSS for days 1–4 was calculated as the mean of the 4 daily nasal symptom scores across study days 1 to 4, where lower scores mean better nasal symptoms.[2]

Secondary outcomes included ANSS over days 1–7 and Total Symptom Score (TSS) averages over days 1–4 and 1–7.[2]

TSS added nasal symptoms plus headache, muscle ache, chills, sore throat, and cough, each rated 0–3, for a total range of 0–24.[2]

In the nasal tolerability and safety study, the primary outcomes included the incidence of nasal mucosal changes of ≥ Grade 1B from baseline to day 8 using a nasal mucosal grading scale.[1]

The grading scale described Grade 0 as no abnormal findings, Grade 1A as focal irritation (inflammation, erythema, or hyperemia), Grade 1B as superficial erosion, and Grade 2 as moderate erosion.[1]

The study also tracked incidence of moderate or severe mucosal bleeding using a bleeding scale from 0 (none) to 3 (severe).[1]

Another primary outcome was incidence of moderate or severe crusting of mucosa using a crusting scale from 0 (none) to 3 (severe).[1]

In the pruritus study, itch intensity was measured using a visual analog scale (VAS) from 0 (no itch) to 10 (most itch imaginable) over 10 minutes after itch induction for histaminergic and non-histaminergic itch conditions.[3]

The primary outcomes compared peak itch intensity between the vehicle gel and the active acetaminophen gel treatments during both non-histaminergic itch induction (cowhage) and histaminergic itch induction.[3]

Safety monitoring: vital signs and laboratory testing

In the healthy adult nasal tolerability study, all adverse events reported by participants were recorded from baseline to day 8.[1]

Vital signs included change from baseline in blood pressure, measured three times after sitting for 5 minutes using an automated validated device, with the mean of the three readings recorded.[1]

Pulse was also measured three times after sitting for 5 minutes, with the mean recorded.[1]

Respiration rate was measured by counting breaths for one minute.[1]

Oral body temperature was measured, with a reference range described as 35.0°C to 37.5°C.[1]

Laboratory monitoring included hematology tests such as hemoglobin, hematocrit, red blood cell count (including indices like MCH, MCV, and MCHC), white blood cell count with differential, and platelet count.[1]

Clinical chemistry included electrolytes (sodium, potassium, chloride, calcium, phosphorous), substrates (BUN, creatinine, total bilirubin, total protein, albumin, uric acid, and C-reactive protein), and enzymes (AST, ALT, ALP, GGT, and CK).[1]

Virus serology testing included hepatitis B surface antigen, hepatitis B core antibody (IgG + IgM), hepatitis C antibody, and HIV-1 and HIV-2 antibodies.[1]

Urinalysis included specific gravity, nitrite, protein including microalbuminuria, glucose, ketones, and blood white and red blood cell sediments.[1]

A urine drug and cotinine screen tested for cotinine and substances including barbiturates, benzodiazepines, amphetamines, cocaine, opiates, and cannabis.[1]

Pregnancy testing and fertility assessments used a urine dipstick test in this study’s procedures.[1]

Turner syndrome trial record: Carbomer 980 listed as a gelling agent product

A European trial record about testosterone replacement therapy in women with Turner syndrome lists “CARBOMER 980” as a medicinal product entry described as an eye gel and as a gelling agent, with a stated maximum daily dose amount and maximum treatment period in the record’s product details.[4]

The same record describes primary endpoints focused on changes in body composition measured by DXA scan (including bone mass, fat mass, and lean muscle mass) and other measures like abdominal circumference and weight.[4]

It also lists multiple secondary endpoints, including quality of life, inflammatory markers, sexual function, intramuscular sex hormone levels, blood volume and hemoglobin mass, coagulation parameters, metabolic parameters, neurocognitive function, hypothalamus structure, and fitness-related measures such as VO2-max and muscle strength.[4]

Topic What the clinical trials show
How Carbomer 980 is used Used in a nasal spray gel (1146A) for common cold studies and used as a topical vehicle gel in an itch study; also listed as an eye gel/gelling agent product in a Turner syndrome trial record.
Main conditions studied Common cold (symptom severity and nasal safety) and pruritus/itch (as a comparison gel base).
Key safety focus (nasal study) Nasal lining irritation/erosion, bleeding, and crusting graded over time; adverse events and vital signs/labs monitored.
Key symptom measures (common cold efficacy study) Nasal Symptom Score and Total Symptom Score averaged across several days, using 0–3 severity ratings per symptom.
How comparison groups were handled Placebo/vehicle gels were used as comparators (vehicle without carbomer 980 for nasal spray; vehicle gel in itch study).

FAQ

  • What is Carbomer 980 in these clinical trials? In these trials, Carbomer 980 is used as a gel-forming ingredient. It is part of a test nasal spray gel (called 1146A) and it is also used in a topical “vehicle” gel (a gel base that does not contain the active itch-relief drug).
  • What conditions were studied with Carbomer 980 products? Carbomer 980 was studied in trials related to the common cold (as a nasal spray gel) and it appeared in a pruritus (itching) study as the vehicle gel. It was also listed as an eye gel product and as a gelling agent in a Turner syndrome trial record.
  • How was Carbomer 980 given in the common cold nasal spray studies? In the studies, Carbomer 980 gel was delivered inside the nose using a nasal spray. Dosing details included multiple actuations (sprays) per nostril per dose, with each actuation measured in microliters (µL) and described as an equivalent weight in milligrams (mg).
  • What safety checks were done in the nasal tolerability study? Researchers examined the nasal lining (nasal mucosa) for irritation, small surface damage (erosion), bleeding, and crusting using grading scales. They also tracked adverse events and measured vital signs (like blood pressure and pulse) and lab tests (blood tests, chemistry, urine tests, and virus blood tests called serology).
  • How did the common cold efficacy study measure symptom improvement? Participants rated their symptoms using scoring systems. A nasal symptom score added up runny nose, blocked nose, and sneezing, each rated from absent to severe. A total symptom score included nasal symptoms plus other symptoms like headache, muscle ache, chills, sore throat, and cough, also rated from absent to severe.

Ongoing Clinical Trials on CARBOMER 980

  • Study on Testosterone and Isopropyl Myristate for Women with Turner Syndrome

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

Glossary

  • Carbomer 980: A gel-forming polymer (a type of large molecule) used to make gels thicker and more stable. In these trials it was part of a nasal gel spray product and also used in a topical gel base (vehicle).
  • Polymer: A large molecule made of repeating units. Polymers can change the thickness and texture of medicines, helping them stay in place (for example, as a gel).
  • Topical: Applied to the surface of the body, usually the skin. In one study, topical gels were applied to a small area of the forearm.
  • Intranasal: Given inside the nose. The nasal spray studies delivered the gel into each nostril.
  • Nasal mucosa (nasal lining): The moist tissue inside the nose. Trials checked it for irritation, bleeding, crusting, and erosion (surface damage).
  • Tolerability: How well the body (or a local area like the nose) can handle a product without unacceptable irritation or side effects.
  • Vehicle (vehicle gel): A base gel without the active medicine. It is used as a comparison to help researchers see whether the active drug adds benefit beyond the gel base.
  • Placebo-controlled: A study design where one group receives the test product and another group receives a placebo (a comparison product designed not to include the key active component being tested).
  • Randomized: Participants are assigned to different study groups by chance, which helps reduce bias.
  • Double-blind: A study design where participants and study staff who interact with participants generally do not know which treatment is given, helping reduce bias.
  • Single-blinded: A study design where one side (often the participant) does not know which treatment is used, but the other side may know.
  • Parallel-group: A study design where different groups receive different treatments during the same time period (rather than each person trying every treatment).
  • Nasal mucosal grading scale: A scoring system used to rate changes in the nasal lining: Grade 0 (normal), Grade 1A (irritation/redness), Grade 1B (superficial erosion), Grade 2 (moderate erosion).
  • Erythema / Hyperemia: Medical terms for redness caused by increased blood flow in tissue, which can be a sign of irritation or inflammation.
  • Erosion (superficial mucosal erosion): Small surface damage to the lining tissue (here, inside the nose).
  • Crusting of mucosa: Dry crusts forming on the nasal lining. Trials graded crusting from none to severe.
  • Adverse event: Any unwanted medical problem reported during a study, whether or not it is clearly caused by the study product.
  • Blood pressure (systolic and diastolic): A vital sign measured in arteries. Systolic is the pressure when the heart pumps; diastolic is the pressure when the heart relaxes.
  • Respiration rate: How many breaths a person takes in one minute.
  • Hematology: Blood tests that measure parts of blood such as red blood cells, white blood cells, and platelets.
  • Clinical chemistry: Blood tests that measure salts (electrolytes), kidney and liver-related substances, inflammation markers, and enzymes.
  • Serology: Blood testing for signs of certain infections (in these trials: hepatitis B, hepatitis C, and HIV).
  • Urinalysis: Urine testing that can look for signs of infection, kidney issues, blood, sugar, protein, and other changes.
  • Cotinine: A substance measured in urine that indicates nicotine exposure from tobacco.
  • Nasal Symptom Score (NSS): A symptom score adding runny nose, blocked nose, and sneezing. Each symptom is rated 0 (absent) to 3 (severe).
  • Average Nasal Symptom Score (ANSS): The average of daily nasal symptom scores over a set number of days (for example days 1–4 or days 1–7). Lower scores mean fewer or milder nasal symptoms.
  • Total Symptom Score (TSS): A broader symptom score that includes nasal symptoms plus other common cold symptoms such as headache, muscle ache, chills, sore throat, and cough.
  • Visual Analog Scale (VAS): A way to rate symptoms on a line or scale (for itch in the study, from 0 meaning no itch to 10 meaning the most itch imaginable).
  • Histaminergic itch: Itch caused through histamine pathways (histamine is a chemical involved in allergic reactions).
  • Non-histaminergic itch: Itch that does not mainly depend on histamine pathways. In the study, this type of itch was induced using cowhage.
  • Cowhage: A plant material used in research to trigger a non-histaminergic itch sensation.
  • Actuation: One spray from a spray device. Trials describe dosing as a number of actuations per nostril.
  • Microliter (µL): A very small unit of liquid volume used to describe how much liquid comes out per spray.
  • Milligram (mg): A unit of weight used to describe the amount of product delivered.
  • DXA scan (dual-energy X-ray absorptiometry): A body scan that measures bone mass and body composition (fat and lean mass). It was listed as a main measurement in the Turner syndrome trial record.
  • Transdermal use: Delivered through the skin, often using a gel or patch. Carbomer 980 was listed as an eye gel product and as a gelling agent with a transdermal route in a Turner syndrome trial record.
  • Turner syndrome: A genetic condition affecting females that can involve hormone-related health needs. One trial record focused on testosterone replacement therapy in women with Turner syndrome and listed carbomer 980 as a gelling agent product.

References

  1. https://clinicaltrials.gov/study/NCT02832362
  2. https://clinicaltrials.gov/study/NCT03005067
  3. https://clinicaltrials.gov/study/NCT03997851
  4. https://clinicaltrials.eu/trial/study-on-testosterone-and-isopropyl-myristate-for-women-with-turner-syndrome/