---
title: A Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds
nct_id: NCT03300466
overall_status: COMPLETED
phase: NA
sponsor: Galderma R&D
study_type: INTERVENTIONAL
primary_condition: Nasolabial Fold
countries: Sweden
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03300466.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03300466"
ct_last_update_post_date: 2022-08-26
last_seen_at: "2026-05-12T07:08:29.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds

**Official Title:** A Randomized, Controlled, Evaluator-blinded, Split Face Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds

**NCT ID:** [NCT03300466](https://clinicaltrials.gov/study/NCT03300466)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** Galderma R&D
- **Conditions:** Nasolabial Fold, Safety
- **Start Date:** 2017-10-02
- **Completion Date:** 2019-04-24
- **CT.gov Last Update:** 2022-08-26

## Brief Summary

This is a study to assess the performance and safety of GP0045 when injected in the nasolabial folds.

There is an 18 months follow up period.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Ability to adequately understand the verbal explanations and the written subject information provided in local language and ability to give consent to participate in the study
* Signed and dated informed consent to participate in the study, including photo consent
* Subjects with intent to undergo correction of both nasolabial folds

Exclusion Criteria:

* Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel
* Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics
* Any condition (medical or other) that, in the opinion of the Investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study)
* Participation in any other clinical study with an investigational product within 30 days before treatment
```

## Arms

- **GP0045** (EXPERIMENTAL) — Treatment with GP0045
- **Comparator** (ACTIVE_COMPARATOR) — Treatment with active comparator

## Interventions

- **GP0045** (DEVICE) — Hyaluronic acid gel
- **Comparator** (DEVICE) — Hyaluronic acid gel

## Primary Outcomes

- **Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale** _(time frame: 6 months)_ — 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.

## Secondary Outcomes

- **Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale** _(time frame: 2 weeks, 3, 9, 12, 15 and 18 months)_

## Locations (1)

- Q-Med, Uppsala, Sweden

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.q-med|uppsala||sweden` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03300466.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03300466*  
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