Study to Compare 2 Botulinum Type A Toxins in the Treatment of Glabellar Frown Lines

NCT04763265 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CPH-201-201461
• Study Type: interventional
• Target: 208
• Locations: 3 countries
• Sites: 5

Brief 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.

Conditions

Frown Lines

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  Weeks 1, 2, 4, 8, 12 and 16

• Time to Onset of Effect Based on Independent Investigator Assessment and Subject Assessment

  From treatment at Day 0 to Week 4

• Duration of Effect Based on Independent Investigator Assessment and Subject Assessment

  16 Weeks

Study Arms (2)

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).

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).

Biological: Botulinum toxin A "Botox Cosmetics"

Interventions

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.

Group A (n=100): BoNT/A-DP (20 U, 0.5 mL)

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.

Group B (n=100): Botox Cosmetic (20 U, 0.5 mL)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has a stable medical condition with no uncontrolled systemic disease.
• Female subjects of childbearing potential must test negative for pregnancy and agree to use highly effective birth control during the course of the study.
• Subjects who wear glasses must be able to adequately self-assess the severity of their glabellar lines (according to the GLS-S), without glasses obstructing the forehead area.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Croma-Pharma GmbH: lead
• Hugel: collaborator

Study Sites (5)

ATS Clinical Research

Santa Monica, California, 90404, United States

Location

Skin Research Institute LLC

Coral Gables, Florida, 33146, United States

Location

Monika Sulovsky

Vienna, 1010, Austria

Location

Institute Of Cosmetic

Oakville, Ontario, L6J7W5, Canada

Location

Sweat Clinics of Canada

Toronto, Ontario, M5R3N8, Canada

Location

Results Point of Contact

• Title: Clinical Development - Head of Clinical Operations
• Organization: Croma Pharma GmbH

clinical.studies@croma.at

+43 2262 684680

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Eligible subjects will be randomized at Baseline (Day 0) to Group A or B in a 1:1 randomization scheme. Investigators and subjects will be blinded to the treatment administered and will evaluate the severity of glabellar lines independently. The subjects should perform their assessment independently and ideally before the investigator, to ensure they are not biased by the investigator. The same investigator must complete the Baseline assessments and FWS at Week 4 (primary endpoint assessments) for a given subject.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 21, 2021
• Study Start: June 24, 2020
• Primary Completion: November 5, 2020
• Study Completion: February 1, 2021
• Last Updated: March 18, 2025
• Results First Posted: March 18, 2025

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); AU (1); CA (2)