Trial Outcomes & Findings for A Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds (NCT NCT03300466)

Last Updated: 2022-08-26

Results Overview

The scale is a 5-graded NLF wrinkle severity scale ranging from absent (Grade 1) to severe (Grade 5). The response rate was defined as the percentage of subjects with at least 1 grade improvement in NLF wrinkle severity. Assessment made by blinded evaluator.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

6 months

Results posted on

2022-08-26

Participant Flow

Participant milestones

Participant milestones
Measure	GP0045 in Right NLF and Comparator in Left NLF Treatment with GP0045 in right NLF (nasolabial fold) and comparator in left NLF GP0045: Hyaluronic acid gel Comparator: Hyaluronic acid gel	Comparator in Right NLF and GP0045 in Left NLF Treatment with comparator in right NLF and GP0045 in left NLF GP0045: Hyaluronic acid gel Comparator: Hyaluronic acid gel
Overall Study STARTED	10	10
Overall Study COMPLETED	9	10
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GP0045 in Right NLF and Comparator in Left NLF n=10 Participants Treatment with GP0045 in right NLF and comparator in left NLF GP0045: Hyaluronic acid gel Comparator: Hyaluronic acid gel	Comparator in Right NLF and GP0045 in Left NLF n=10 Participants Treatment with comparator in right NLF and GP0045 in left NLF GP0045: Hyaluronic acid gel Comparator: Hyaluronic acid gel	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=93 Participants	8 Participants n=4 Participants	16 Participants n=27 Participants
Age, Categorical >=65 years	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Sex: Female, Male Female	10 Participants n=93 Participants	10 Participants n=4 Participants	20 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	10 Participants n=93 Participants	10 Participants n=4 Participants	20 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment Sweden	10 participants n=93 Participants	10 participants n=4 Participants	20 participants n=27 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	GP0045 n=19 Participants Treatment with GP0045 GP0045: Hyaluronic acid gel	Comparator n=19 Participants Treatment with comparator Comparator: Hyaluronic acid gel
Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale	63.2 percentage of participants	68.4 percentage of participants

SECONDARY outcome

Timeframe: 2 weeks, 3, 9, 12, 15 and 18 months

Outcome measures

Outcome measures
Measure	GP0045 n=19 Participants Treatment with GP0045 GP0045: Hyaluronic acid gel	Comparator n=19 Participants Treatment with comparator Comparator: Hyaluronic acid gel
Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale 2 weeks	100 percentage of participants	100 percentage of participants
Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale 3 months	89.5 percentage of participants	89.5 percentage of participants
Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale 9 months	36.8 percentage of participants	26.3 percentage of participants
Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale 12 months	15.8 percentage of participants	21.1 percentage of participants
Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale 15 months	10.5 percentage of participants	5.3 percentage of participants
Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale 18 months	0 percentage of participants	0 percentage of participants

Adverse Events

GP0045 in Right NLF and Comparator in Left NLF

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Comparator in Right NLF and GP0045 in Left NLF

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GP0045 in Right NLF and Comparator in Left NLF n=10 participants at risk Treatment with GP0045 in right NLF (nasolabial fold) and comparator in left NLF	Comparator in Right NLF and GP0045 in Left NLF n=10 participants at risk Treatment with comparator in right NLF and GP0045 in left NLF
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	10.0% 1/10 • Number of events 1 • 18-19 months (depending on how long screening), from screening visit to final study visit.	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.

Other adverse events

Additional Information

Clinical Project Manager

Q-Med AB

Phone: +46184749000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	GP0045 in Right NLF and Comparator in Left NLF n=10 participants at risk Treatment with GP0045 in right NLF (nasolabial fold) and comparator in left NLF	Comparator in Right NLF and GP0045 in Left NLF n=10 participants at risk Treatment with comparator in right NLF and GP0045 in left NLF
Gastrointestinal disorders Oral disorder	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.	10.0% 1/10 • Number of events 2 • 18-19 months (depending on how long screening), from screening visit to final study visit.
General disorders Implant site erythema	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.	10.0% 1/10 • Number of events 2 • 18-19 months (depending on how long screening), from screening visit to final study visit.
General disorders Implant site hypoesthesia	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.	10.0% 1/10 • Number of events 1 • 18-19 months (depending on how long screening), from screening visit to final study visit.
General disorders Implant site mass	10.0% 1/10 • Number of events 1 • 18-19 months (depending on how long screening), from screening visit to final study visit.	10.0% 1/10 • Number of events 1 • 18-19 months (depending on how long screening), from screening visit to final study visit.
General disorders Implant site pain	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.	70.0% 7/10 • Number of events 17 • 18-19 months (depending on how long screening), from screening visit to final study visit.
General disorders Implant site papules	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.	10.0% 1/10 • Number of events 1 • 18-19 months (depending on how long screening), from screening visit to final study visit.
General disorders Implant site pruritus	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.	10.0% 1/10 • Number of events 2 • 18-19 months (depending on how long screening), from screening visit to final study visit.
General disorders Implant site swelling	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.	40.0% 4/10 • Number of events 11 • 18-19 months (depending on how long screening), from screening visit to final study visit.
Cardiac disorders Bradycardia	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.	10.0% 1/10 • Number of events 1 • 18-19 months (depending on how long screening), from screening visit to final study visit.
Ear and labyrinth disorders Vertigo	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.	10.0% 1/10 • Number of events 1 • 18-19 months (depending on how long screening), from screening visit to final study visit.
Eye disorders Eye allergy	10.0% 1/10 • Number of events 1 • 18-19 months (depending on how long screening), from screening visit to final study visit.	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.
Eye disorders Iritis	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.	10.0% 1/10 • Number of events 1 • 18-19 months (depending on how long screening), from screening visit to final study visit.
Gastrointestinal disorders Dyspepsia	10.0% 1/10 • Number of events 1 • 18-19 months (depending on how long screening), from screening visit to final study visit.	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.
Gastrointestinal disorders Gingival recession	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.	10.0% 1/10 • Number of events 1 • 18-19 months (depending on how long screening), from screening visit to final study visit.
Gastrointestinal disorders Toothache	30.0% 3/10 • Number of events 3 • 18-19 months (depending on how long screening), from screening visit to final study visit.	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.
General disorders Nodule	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.	10.0% 1/10 • Number of events 2 • 18-19 months (depending on how long screening), from screening visit to final study visit.
Hepatobiliary disorders Cholangitis	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.	10.0% 1/10 • Number of events 1 • 18-19 months (depending on how long screening), from screening visit to final study visit.
Infections and infestations Gastroenteritis	10.0% 1/10 • Number of events 1 • 18-19 months (depending on how long screening), from screening visit to final study visit.	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.
Infections and infestations Herpes zoster	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.	10.0% 1/10 • Number of events 1 • 18-19 months (depending on how long screening), from screening visit to final study visit.
Infections and infestations Influenza	20.0% 2/10 • Number of events 2 • 18-19 months (depending on how long screening), from screening visit to final study visit.	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.
Infections and infestations Nasopharyngitis	50.0% 5/10 • Number of events 5 • 18-19 months (depending on how long screening), from screening visit to final study visit.	70.0% 7/10 • Number of events 8 • 18-19 months (depending on how long screening), from screening visit to final study visit.
Infections and infestations Oral herpes	10.0% 1/10 • Number of events 1 • 18-19 months (depending on how long screening), from screening visit to final study visit.	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.
Infections and infestations Pneumonia	10.0% 1/10 • Number of events 1 • 18-19 months (depending on how long screening), from screening visit to final study visit.	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.
Infections and infestations Tooth infection	10.0% 1/10 • Number of events 1 • 18-19 months (depending on how long screening), from screening visit to final study visit.	10.0% 1/10 • Number of events 1 • 18-19 months (depending on how long screening), from screening visit to final study visit.
Infections and infestations Urinary tract infection	10.0% 1/10 • Number of events 4 • 18-19 months (depending on how long screening), from screening visit to final study visit.	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.	10.0% 1/10 • Number of events 1 • 18-19 months (depending on how long screening), from screening visit to final study visit.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.	10.0% 1/10 • Number of events 1 • 18-19 months (depending on how long screening), from screening visit to final study visit.
Injury, poisoning and procedural complications Limb injury	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.	10.0% 1/10 • Number of events 1 • 18-19 months (depending on how long screening), from screening visit to final study visit.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.	10.0% 1/10 • Number of events 1 • 18-19 months (depending on how long screening), from screening visit to final study visit.
Metabolism and nutrition disorders Hyperlipidemia	10.0% 1/10 • Number of events 1 • 18-19 months (depending on how long screening), from screening visit to final study visit.	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.
Metabolism and nutrition disorders Overweight	10.0% 1/10 • Number of events 1 • 18-19 months (depending on how long screening), from screening visit to final study visit.	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 1/10 • Number of events 1 • 18-19 months (depending on how long screening), from screening visit to final study visit.	10.0% 1/10 • Number of events 1 • 18-19 months (depending on how long screening), from screening visit to final study visit.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.	10.0% 1/10 • Number of events 1 • 18-19 months (depending on how long screening), from screening visit to final study visit.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.	10.0% 1/10 • Number of events 1 • 18-19 months (depending on how long screening), from screening visit to final study visit.
Musculoskeletal and connective tissue disorders Neck pain	10.0% 1/10 • Number of events 1 • 18-19 months (depending on how long screening), from screening visit to final study visit.	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.
Nervous system disorders Headache	30.0% 3/10 • Number of events 5 • 18-19 months (depending on how long screening), from screening visit to final study visit.	40.0% 4/10 • Number of events 9 • 18-19 months (depending on how long screening), from screening visit to final study visit.
Vascular disorders Hematoma	10.0% 1/10 • Number of events 1 • 18-19 months (depending on how long screening), from screening visit to final study visit.	0.00% 0/10 • 18-19 months (depending on how long screening), from screening visit to final study visit.