Frown LinesPhase 2H2HNCT04763265
Study to Compare 2 Botulinum Type A Toxins in the Treatment of Glabellar Frown Lines
A Phase 2 study testing Botulinum toxin A "BoNT/A-DP" and Botulinum toxin A "Botox Cosmetics" in people with Frown Lines, run by Croma-Pharma GmbH at 5 sites in 3 countries.
Trial summary
The purpose of the study is to provide preliminary comparative data on BoNT/A-DP versus Botox Cosmetic. Subsequently the sample size is primarily based on clinical judgement and practical considerations. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Frown Lines
- What is being tested?
- Botulinum toxin A "BoNT/A-DP" and Botulinum toxin A "Botox Cosmetics"
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 24 Jun 2020to 1 Feb 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Previous treatment with any serotype of botulinum toxin for any indication within the 12 months prior to Screening, or any planned treatment with botulinum toxin of any serotype for any reason during the study (other than the investigational treatment).
- Known hypersensitivity to either study medication or its excipients.
- Any medical condition that may place the subject at increased risk due to exposure to botulinum toxin, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, profound atrophy or weakness in the target muscles, or any other condition (at the investigator's discretion) that might interfere with neuromuscular function or contraindicate botulinum toxin therapy.
- Facial laser or light treatment, microdermabrasion, superficial peels or retinoid therapy within the three months prior to Screening or planned during the study.
- o Apart from the procedures specified above, previous treatment with any facial aesthetic procedure in the glabellar area (including chemical peeling, injection with biodegradable fillers, photo rejuvenation) within 12 months prior to Screening or planned during the study.
- Previous insertion of permanent material in the glabellar area, or planned insertion during the study.
Show all 17Show fewer
- Any planned or history of surgery in the glabellar area and/or canthal line area, or scars in the glabellar and/or canthal line.
- Active skin disease/infection or irritation at the treatment area.
- Inability to substantially lessen glabellar frown lines and or lateral canthal lines even by physically spreading them apart.
- Use of a muscle relaxant within 2 weeks prior to Screening, or planned use during the study.
- Marked facial asymmetry or ptosis of eyelid and/or eyebrow, or current facial palsy or neuromuscular junction disorders as judged by the investigator.
- Pregnant, breastfeeding or planning to become pregnant during the study.
- Use of prohibited medication including anticholinergic drugs, or drugs which could interfere with neuromuscular function, including aminoglycoside antibiotics and curare-like compounds within 2 weeks prior to Screening or planned during the study.
- Planned surgery with general anesthetic (use of local anesthetic outside the glabellar area is permitted).
- Participation in another clinical study within one month of Screening and throughout the study.
- Previous participation in another botulinum toxin aesthetic study, which involved the treatment of glabellar, lines in combination with canthal lines and/or forehead lines in the previous 18 months.
- Chronic drug or alcohol abuse (as per investigator discretion).
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States2 sites
Skin Research Institute LLC
Coral Gables, Florida, 33146
ATS Clinical Research
Santa Monica, California, 90404
Canada2 sites
Institute Of Cosmetic
Oakville, Ontario, L6J7W5
Sweat Clinics of Canada
Toronto, Ontario, M5R3N8
About this study
Official title: A Double-Blinded, Randomized, Controlled Study to Compare the Efficacy, Time to Onset, and Duration of Effect of Botulinum Type A Toxins in the Treatment of Glabellar Frown Lines
The purpose of the study is to provide preliminary comparative data on BoNT/A-DP versus Botox Cosmetic. Subsequently the sample size is primarily based on clinical judgement and practical considerations.
Read the detailed description
This will be a multi-center, randomized, double-blind, comparator-controlled study. The study will take place in the EU, US and Canada.
To allow all subjects to profit from treatment and to obtain adequate data for BoNT/A DP treatment, the study will be comprised of a double-blinded treatment comparing BoNT/A-DP with Botox Cosmetic (ratio 1:1). Primary and secondary endpoints will compare efficacy, safety and subject satisfaction after a single treatment of the investigational BoNT/A DP to an existing commercially available product (Botox Cosmetic).
Two hundred subjects will be enrolled, which should allow for a precise estimate of response rate and for post-hoc sensitivity analyses.
The duration of study participation for each subject will be up to 18 weeks, to include screening (maximum of 2 weeks; re-screening will not be permitted), and a single treatment (comprised of one injection at five injection points) of BoNT/A-DP (Group A) or Botox Cosmetic (Group B) followed by six efficacy and safety follow-up visits. A total of 200 subjects will be randomized 1:1 to Group A or Group B at Baseline. Both investigators and subjects will be blinded to treatment. Investigators and subjects will evaluate the severity of glabellar lines independently.
- Conditions
- Frown Lines
- Being tested
- Botulinum toxin A "BoNT/A-DP", Botulinum toxin A "Botox Cosmetics"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin A "BoNT/A-DP"Biological
To assess the efficacy of treatment with BoNT/A-DP in reducing the severity of glabellar frown lines at maximum frown.
Botulinum toxin A "Botox Cosmetics"Biological
To assess the efficacy of treatment with Botox Cosmetics in reducing the severity of glabellar frown lines at maximum frown.
| Study group | Role | What they receive |
|---|---|---|
| Group A (n=100): BoNT/A-DP (20 U, 0.5 mL) | Active comparator | The injection sites should be prepared according to standard clinical procedures..
A volume of 0.5 mL of the properly reconstituted BoNT/A-DP should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U). Receives: Biological: Botulinum toxin A "BoNT/A-DP" |
| Group B (n=100): Botox Cosmetic (20 U, 0.5 mL) | Active comparator | The injection sites should be prepared according to standard clinical procedures.
A volume of 0.5 mL of the properly reconstituted Botox Cosmetic should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U). Receives: Biological: Botulinum toxin A "Botox Cosmetics" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial Wrinkle Scale (FWS) Score of 0 or 1 and an Improvement of ≥ 1 Points in FWS Score (at Maximum Frown) at Week 4 Visit Relative to Baseline, Based on Both the Investigators´ and the Subjects´ In-clinic Assessments.
The primary endpoint is the percentage of subjects among BoNT/A-DP and Botox Cosmetic groups with a Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 1 points in FWS score (at maximum frown) at week 4 visit (of the first treatment cycle) relative to baseline (responders), based on both the investigators' and the subjects' in-clinic assessments. Thus, the primary endpoint is a composite endpoint comprising investigator and subject assessments of treatment effectiveness. FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles. Subjects with missing in-clinic assessments with the FWS at Baseline or Week 4 were assigned as non-responders.
Measured: week 4
Secondary outcomes (9)
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16
The percentage of responders based on the independent investigator assessment and subject assessment at Weeks 1, 2, 8, 12 and 16 after a single treatment with BoNT/A-DP and compared to a single treatment of Botox Cosmetic. Responder is defined as having a Facial Wrinkle Scale (FWS) score of 0 or 1 and at least 1 point reduction in FWS score at maximum frown over Baseline, on the 4-point FWS. FWS scores are ranked as 0 (no facial wrinkles), 1 (mild facial wrinkles), 2 (moderate facial wrinkles) and 3 (severe facial wrinkles). Subjects with missing in-clinic assessments with the FWS at Baseline or the respective visit were assigned as non-responders.
Measured: Weeks 1, 2, 8, 12 and 16
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16
The percentage of responders based on the independent investigator assessment and subject assessment at Weeks 1, 2, 4, 8, 12 and 16 after a single treatment with BoNT/A-DP and compared to a single treatment of Botox Cosmetic. Responder is defined as having a Facial Wrinkle Scale (FWS) score of 0 or 1 and at least 2 point reduction in FWS score at maximum frown over Baseline, on the 4-point FWS. FWS scores are ranked as 0 (no facial wrinkles), 1 (mild facial wrinkles), 2 (moderate facial wrinkles) and 3 (severe facial wrinkles). Subjects with missing in-clinic assessments with the FWS at Baseline or the respective visit were assigned as non-responders.
Measured: Weeks 1, 2, 4, 8, 12 and 16
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16
The percentage of responders based on the independent investigator assessment and subject assessment at Weeks 1, 2, 4, 8, 12 and 16 after a single treatment with BoNT/A-DP and compared to a single treatment of Botox Cosmetic. Responder is defined as having a Facial Wrinkle Scale (FWS) score of 0 or 1 and at least 1 point reduction in FWS score at rest over Baseline, on the 4-point FWS. FWS scores are ranked as 0 (no facial wrinkles), 1 (mild facial wrinkles), 2 (moderate facial wrinkles) and 3 (severe facial wrinkles). Subjects with missing in-clinic assessments with the FWS at Baseline or the respective visit were assigned as non-responders.
Measured: Weeks 1, 2, 4, 8, 12 and 16
Time to Onset of Effect Based on Independent Investigator Assessment and Subject Assessment
Time to onset of effect in days, as measured at Weeks 1, 2, and 4, based on independent investigator and subject assessments after a single treatment with BoNT/A-DP and compared to Botox Cosmetic. Onset of effect is defined as at least 1 point improvement in Glabellar Line Scale - Investigator (GLS-I) and Glabellar Line Scale - Subject (GLS-S) score relative to Baseline at maximum frown in glabellar lines. GLS-I and GLS-S both use the same 4-point scale, ranked as 0 (No lines/minimal lines), 1 (Mild lines), 2 (Moderate lines) and 3 (Severe lines).
Measured: From treatment at Day 0 to Week 4
Duration of Effect Based on Independent Investigator Assessment and Subject Assessment
For subjects who are responders at week 4, duration of effect in days is assessed based on independent investigator and subject assessments after a single treatment with BoNT/A-DP and compared to Botox Cosmetic. Responder is defined as having a Facial Wrinkle Scale (FWS) score of 0 or 1 and at least 1 point reduction in FWS score at maximum frown over Baseline, on the 4-point FWS. FWS scores are ranked as 0 (no facial wrinkles), 1 (mild facial wrinkles), 2 (moderate facial wrinkles) and 3 (severe facial wrinkles). Effect is deemed to be lost when scores return to Baseline or worse values. Duration of effect is defined as (the date that loss of response occurred) - (date of single study treatment ) + 1.
Measured: 16 Weeks
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Summary of FACE-Q satisfaction with outcome scale based on subject assessment at weeks 4, 12 and 16 after a single treatment and compared to Botox Cosmetic. The FACE-Q Satisfaction with Outcome scale is a patient-reported outcome measure designed to assess a patient's satisfaction with the results of a facial aesthetic procedure. This scale comprises six items, each with four response options: "definitely agree," "somewhat agree," "somewhat disagree," and "definitely disagree."
Measured: Weeks 4, 12 and 16
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs)
Frequency, seriousness and severity of treatment-emergent adverse events (TEAEs), serious AEs (SAEs) and AEs of special interest (AESIs), as well as causal relationship to the study medication and the study procedure, during the entire study period. A subject with multiple occurrences of an adverse event is counted only once within the worst severity category.
Measured: through study completion, an average of 16 weeks
Change From Baseline in Blood Pressure at Weeks 1, 4, 12 and 16
Summary of change from baseline in diastolic/systolic blood pressure at weeks 1, 4, 12 and 16 after a single treatment and compared to Botox Cosmetic.
Measured: Weeks 1, 4, 12, and 16
Change From Baseline in Pulse Rate at Weeks 1, 4, 12 and 16
Summary of change from baseline in pulse rate at weeks 1, 4, 12 and 16 after a single treatment and compared to Botox Cosmetic.
Measured: Weeks 1, 4, 12, and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start24 Jun 2020
- Primary completion5 Nov 2020
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Frown LinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center, randomized, double-blind, comparator-controlled study. The study will take place in the EU, US and Canada. The benefit of participation in this study is the expected reduction in the severity of glabellar frown lines. All subjects will benefit from free medical screenings and follow up.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Croma-Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hugel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763265
- Sponsor's protocol ID
- CPH-201-201461
- Acronym
- H2H
- Status last verified
- Jan 2021
- First submitted
- 25 Jan 2021
- Last updated
- 18 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blinded, Randomized, Controlled Study to Compare the Efficacy, Time to Onset, and Duration of Effect of Botulinum Type A Toxins in the Treatment of Glabellar Frown Lines
- ClinicalTrials.gov ID
- NCT04763265
- Acronym / sponsor ID
- H2H / CPH-201-201461
- Conditions
- Frown Lines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Croma-Pharma GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Hugel
- Study start
- 24 Jun 2020 (actual)
- Primary completion
- 5 Nov 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Posted 18 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to provide preliminary comparative data on BoNT/A-DP versus Botox Cosmetic. Subsequently the sample size is primarily based on clinical judgement and practical considerations.
Detailed description
This will be a multi-center, randomized, double-blind, comparator-controlled study. The study will take place in the EU, US and Canada.
To allow all subjects to profit from treatment and to obtain adequate data for BoNT/A DP treatment, the study will be comprised of a double-blinded treatment comparing BoNT/A-DP with Botox Cosmetic (ratio 1:1). Primary and secondary endpoints will compare efficacy, safety and subject satisfaction after a single treatment of the investigational BoNT/A DP to an existing commercially available product (Botox Cosmetic).
Two hundred subjects will be enrolled, which should allow for a precise estimate of response rate and for post-hoc sensitivity analyses.
The duration of study participation for each subject will be up to 18 weeks, to include screening (maximum of 2 weeks; re-screening will not be permitted), and a single treatment (comprised of one injection at five injection points) of BoNT/A-DP (Group A) or Botox Cosmetic (Group B) followed by six efficacy and safety follow-up visits. A total of 200 subjects will be randomized 1:1 to Group A or Group B at Baseline. Both investigators and subjects will be blinded to treatment. Investigators and subjects will evaluate the severity of glabellar lines independently.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multi-center, randomized, double-blind, comparator-controlled study. The study will take place in the EU, US and Canada. The benefit of participation in this study is the expected reduction in the severity of glabellar frown lines. All subjects will benefit from free medical screenings and follow up.
| Arm | Type | Receives |
|---|---|---|
| Group A (n=100): BoNT/A-DP (20 U, 0.5 mL) | Active comparator | Biological: Botulinum toxin A "BoNT/A-DP"The injection sites should be prepared according to standard clinical procedures.. A volume of 0.5 mL of the properly reconstituted BoNT/A-DP should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration. Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U). |
| Group B (n=100): Botox Cosmetic (20 U, 0.5 mL) | Active comparator | Biological: Botulinum toxin A "Botox Cosmetics"The injection sites should be prepared according to standard clinical procedures. A volume of 0.5 mL of the properly reconstituted Botox Cosmetic should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration. Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (17 listed)
- Previous treatment with any serotype of botulinum toxin for any indication within the 12 months prior to Screening, or any planned treatment with botulinum toxin of any serotype for any reason during the study (other than the investigational treatment).
- Known hypersensitivity to either study medication or its excipients.
- Any medical condition that may place the subject at increased risk due to exposure to botulinum toxin, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, profound atrophy or weakness in the target muscles, or any other condition (at the investigator's discretion) that might interfere with neuromuscular function or contraindicate botulinum toxin therapy.
- Facial laser or light treatment, microdermabrasion, superficial peels or retinoid therapy within the three months prior to Screening or planned during the study.
- o Apart from the procedures specified above, previous treatment with any facial aesthetic procedure in the glabellar area (including chemical peeling, injection with biodegradable fillers, photo rejuvenation) within 12 months prior to Screening or planned during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin A "BoNT/A-DP"To assess the efficacy of treatment with BoNT/A-DP in reducing the severity of glabellar frown lines at maximum frown. | Biological | Group A (n=100): BoNT/A-DP (20 U, 0.5 mL) |
| Botulinum toxin A "Botox Cosmetics"To assess the efficacy of treatment with Botox Cosmetics in reducing the severity of glabellar frown lines at maximum frown. | Biological | Group B (n=100): Botox Cosmetic (20 U, 0.5 mL) |
Primary outcome
Facial Wrinkle Scale (FWS) Score of 0 or 1 and an Improvement of ≥ 1 Points in FWS Score (at Maximum Frown) at Week 4 Visit Relative to Baseline, Based on Both the Investigators´ and the Subjects´ In-clinic Assessments.
Time frame: week 4
The primary endpoint is the percentage of subjects among BoNT/A-DP and Botox Cosmetic groups with a Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 1 points in FWS score (at maximum frown) at week 4 visit (of the first treatment cycle) relative to baseline (responders), based on both the investigators' and the subjects' in-clinic assessments. Thus, the primary endpoint is a composite endpoint comprising investigator and subject assessments of treatment effectiveness. FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles. Subjects with missing in-clinic assessments with the FWS at Baseline or Week 4 were assigned as non-responders.
9 secondary outcomes
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16
Time frame: Weeks 1, 2, 8, 12 and 16
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16
Time frame: Weeks 1, 2, 4, 8, 12 and 16
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16
Time frame: Weeks 1, 2, 4, 8, 12 and 16
Time to Onset of Effect Based on Independent Investigator Assessment and Subject Assessment
Time frame: From treatment at Day 0 to Week 4
Duration of Effect Based on Independent Investigator Assessment and Subject Assessment
Time frame: 16 Weeks
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Time frame: Weeks 4, 12 and 16
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs)
Time frame: through study completion, an average of 16 weeks
Change From Baseline in Blood Pressure at Weeks 1, 4, 12 and 16
Time frame: Weeks 1, 4, 12, and 16
Change From Baseline in Pulse Rate at Weeks 1, 4, 12 and 16
Time frame: Weeks 1, 4, 12, and 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botulinum toxin A "BoNT/A-DP" and Botulinum toxin A "Botox Cosmetics" in people with Frown Lines, run by Croma-Pharma GmbH at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial Wrinkle Scale (FWS) Score of 0 or 1 and an Improvement of ≥ 1 Points in FWS Score (at Maximum Frown) at Week 4 Visit Relative to Baseline, Based on Both the Investigators´ and the Subjects´ In-clinic Assessments. (time frame: week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.