Pharmacokinetics and Safety of ALA in Acne Vulgaris

NCT04044898 | Completed Phase 1

• 1 other identifier: F0014-ALA-201811
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the pharmacokinetics and safety of ALA in patients with moderate and severe acne vulgaris after single dose in different dosages.

Conditions

Acne Vulgaris

Keywords

Acne vulgaris

Outcome Measures

Primary Outcomes (13)

• Maximum Plasma Concentration [Cmax]

  pharmacokinetic parameter

  24 hours postdose

• Area Under the Curve [AUC]

  pharmacokinetic parameter

  24 hours postdose

• Tmax

  pharmacokinetic parameter

  24 hours postdose

• Half-life Time [T1/2]

  pharmacokinetic parameter

  24 hours postdose

• Clearance [CL]

  pharmacokinetic parameter

  24 hours postdose

• Apparent Volume of Distribution [Vd]

  pharmacokinetic parameter

  24 hours postdose

• Maximum Plasma Concentration [Cmax](after deduction of background)

  pharmacokinetic parameter

  24 hours postdose

• Area Under the Curve [AUC](after deduction of background)

  pharmacokinetic parameter

  24 hours postdose

• Tmax(after deduction of background)

  pharmacokinetic parameter

  24 hours postdose

• Half-life Time [T1/2](after deduction of background)

  pharmacokinetic parameter

  24 hours postdose

• Clearance [CL](after deduction of background)

  pharmacokinetic parameter

  24 hours postdose

• Apparent Volume of Distribution [Vd](after deduction of background)

  pharmacokinetic parameter

  24 hours postdose

• Incidence of adverse events

  Number of participants with treatment related adverse events as assessed by physical examination, vital signs, clinical laboratory values, local skin responses

  2 days postdose

Study Arms (2)

Low dose

EXPERIMENTAL

Drug: ALA 5%

High dose

EXPERIMENTAL

Drug: ALA 10%

Interventions

ALA 5% DRUG

prepare 5% ALA solution, apply topically to the affected area for 1.5 hours, single dose

Low dose

ALA 10% DRUG

prepare 10% ALA solution, apply topically to the affected area for 3 hours, single dose

High dose

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female subjects between 18 and 45 years of age (all subjects are male in pilot study);
• Diagnosis of moderate to severe facial acne vulgaris by the clinician according to the Pillsbury International Improvement Classification III-IV criteria;
• Body weight≥50 kg, body mass index (BMI) ≥19 and ≤28 kg/m2；
• Subjects (including male subjects) voluntarily adopt effective physical contraception from 14 days prior to the use of the study drug to 1 month after the end of the study, and have no fertility or donation of sperm/egg plan;
• Subjects voluntarily sign informed consent forms after being informed of the study procedures，requirements and possible adverse reactions of the study drug.

You may not qualify if:

• Suffer from allergic diseases ，suspect or known to have porphyrin disease or known to be allergic to test medication and/or porphyrin， or allergic persons (such as allergies to two or more drugs, food or pollen);
• Allergies to visible light
• Secondary acne patients, such as acne caused by occupational acne and corticosteroids.
• Suffering from malignant tumors and suffering from diseases such as heart, endocrine, blood, liver, immunity, metabolism, urinary system, lungs, nervous system, rheumatism/joint, mental, kidney, etc led the researchers to believe that the subject is not suitable for participating in this study
• Have been treated with systemic Vitamin A acid drugs therapy within 2 months before the study and/or antibiotics or hormonal drugs within 4 weeks before the study
• Used local topical vitamin A acid drugs within the 4 weeks before the study or patients with topical antibiotics, glucocorticoid and other topical treatment of acne drugs within the 2 weeks before the study
• Vaccination within 4 weeks prior to the use of the study drug;
• Severe external injuries were suffered within the first 3 months (90 days) prior to the use of the study drug, or Patients who have undergone surgical treatment may significantly affect the process of studying drugs in vivo or safety assessment;
• Taked clinical trial drugs within 3 months (90 days) prior to the use of the study drug, or be participating in or plan to participate in other clinical trials during the study period.
• Drinking alcohol regularly within 3 months (90 days) prior to the use of the study drug (≥3 times a week, and the average drink is equivalent to 50° white wine ≥200 mL) or can not quit drinking during the study, or alcohol breath test positive
• Smoking cigarettes (more than 10 cigarettes or equivalent of tobacco per day) within 3 months (90 days) prior to the use of the study drug or those who cannot quit smoking during the study;
• Blood loss/blood donation more than 300 mL (except for female physiological blood loss), blood transfusion or blood product use within 3 months (90 days) prior to the use of the study drug, or plan to be blood donors during the study period or 1 month after the end of the study l (30 days) )
• Consumed excessively daily tea, coffee or caffeinated beverages (up to 8 cups per day, 200 mL per cup) within 1 month (30 days) prior to the use of the study drug;
• Drinks or food intake excessive of alcohol or caffeine (coffee, tea, cola, chocolate, etc.) within 48 hours prior to the use of the study drug ;
• Have a history of drug abuse or positive drug abuse screening;

Sponsors & Collaborators

• Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 5, 2019
• Study Start: January 12, 2021
• Primary Completion: July 30, 2021
• Study Completion: December 6, 2021
• Last Updated: March 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)