ClinicalTrials.Veeva

Menu

Determine the Dosing Interval and Optimal Dose of AYP-101 for the Reduction of Submental Fat in Chin Area

A

AMIpharm

Status and phase

Completed
Phase 2

Conditions

Moderate or Severe Submental Fullness

Treatments

Drug: Polyene Phosphatidylcholine
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05266729
AYP-101-202

Details and patient eligibility

About

To determine the dosing interval, optimal dose, evaluate safety, and efficacy of AYP-101 S.C injection for the reduction of Submental Fat (SMF).

Full description

This study is to determine the dosing interval, optimal dose, evaluate safety and efficacy of AYP-101 S.C injection for the reduction of SMF who wish improvement in the appearance of moderate to severe convexity or fullness associated with SMF in adults.

Enrollment

96 patients

Sex

All

Ages

19 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Male and female over 19 and under 65 years old

  • Localized submental fat under chin area and who meet all the following criteria.

    ① Determined as grade 2 (moderate) or 3 (severe) on both using the CR-SMFRS and PR-SMFRS at visit 1

    ② Determined as grade 2 (less satisfied) or less by oneself, using the SSRS at visit 1

  • Stable weight over the last 6 months (body weight change within +/-10%), subject who should refrain from exercise and diet that may affect the study results, and who agreed to remain it for the study period

  • Singed informed consent

Exclusion criteria

  • Allergic to beans, components of the clinical drug, or medical devices which used in this clinical trial (lidocaine, acetaminophen, sterile oil pan, alcohol swab, grid pad, needle, etc.)
  • Central, endocrine, or hereditary obesity (BMI 35kg/m2 or more)
  • History of any treatment (orthognathic surgery, suction lipectomy, PPC or DCA injection) in the neck or chin area
  • History of any treatment such as mesotherapy, carboxy, laser surgery, acupuncture needle, filler, chemical peeling with in 1 year, and a botox surgery within 6 months before screening
  • Judged to be unsuitable subject for the clinical trials; ① Abnormal or sagging skin, ② Noticeable platysma band under the chin area, ③ Less or short chin than normal ④ Chin or neck disease that are considered to have an impact on the clinical trial such as lymphadenopathy, Inflammation, scars, or surgery on the injection area
  • History of or present symptoms of dysphagia
  • Heart disease (cardiac insufficiency, angina, cardiac infarction) or stroke within 6 months before screening
  • Requiring treatment of joint inflammation or a lung disease
  • Uncontrolled hypertension (systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 110 mmHg) or type 2 diabetes mellitus (HbA1c> 9%)
  • Type 1 diabetes mellitus who needs insulin treatment
  • Autoimmune disorder as well as those who takes immunodepressant drugs
  • Hemostatic disorder or those who takes anticoagulant drug such as warfarin and clopidogrel
  • Thyromegaly, thyrotoxicosis, or HIV-positive
  • Diagnosed with malignant tumor within the last 5 years
  • Severe renal dysfunction (serum creatinine > 2.0 mg/dl) or severe dyshepatia (ALT, AST, alkaline phosphatase > maximum rate of normality x 2.5)
  • History of serious psychiatric disease (Depression, schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, anorexia nervosa, etc.)
  • History of taken a drug that can affect body weight or lipid metabolism such as anorectic agent, steroids, thyroid hormones, amphetamine, cyproheptadine, phenothiazine, or drugs that affect absorption, metabolism, and excretion within 3 months before screening
  • History of other clinical trial studies within 6 months before screening
  • Women who are pregnant, breastfeeding, having pregnancy plan, or did not agreed to the contraception (contraceptive pills, contraceptive hormones, IUCD, spermicide, condoms etc.)
  • Judged to be unsuitable subject for the clinical trials

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

96 participants in 3 patient groups, including a placebo group

AYP-101 1
Experimental group
Description:
0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 2 weeks for up to a maximum of 6 treatments.
Treatment:
Drug: Polyene Phosphatidylcholine
AYP-101 2
Experimental group
Description:
0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 2 weeks for up to a maximum of 6 treatments.
Treatment:
Drug: Polyene Phosphatidylcholine
Placebo
Placebo Comparator group
Description:
0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 2 weeks for up to a maximum of 6 treatments.
Treatment:
Drug: Placebo

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems