Pharmacokinetics and Safety of ALA in Acne Vulgaris

A Pharmacokinetics and Safety Study of Aminolevulinic Acid Hydrochloride Topical Powder in Subjects With Moderate to Severe Facial Acne Vulgaris.

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

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: ALA 5%; Drug: ALA 10%

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Huashan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male and female subjects between 18 and 45 years of age (all subjects are male in pilot study);
2. Diagnosis of moderate to severe facial acne vulgaris by the clinician according to the Pillsbury International Improvement Classification III-IV criteria;
3. Body weight≥50 kg, body mass index (BMI) ≥19 and ≤28 kg/m2；
4. 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;
5. Subjects voluntarily sign informed consent forms after being informed of the study procedures，requirements and possible adverse reactions of the study drug.

Exclusion Criteria:

1. 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);
2. Allergies to visible light
3. Secondary acne patients, such as acne caused by occupational acne and corticosteroids.
4. 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
5. 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
6. 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
7. Vaccination within 4 weeks prior to the use of the study drug;
8. 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;
9. 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.
10. 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
11. 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;
12. 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) )
13. 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;
14. 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 ;
15. Have a history of drug abuse or positive drug abuse screening;
16. Hepatitis B surface antigen or hepatitis C virus antibody or treponema pallidum antibody positive or HIV Screening positive;
17. Physical examination (except acne), Vital Signs, laboratory examination (blood routine, urine routine, liver function, renal function, fasting blood glucose, blood lipids, etc).and 12 lead ECG results were judged to be abnormal and clinically significant by clinicians
18. Pregnant or lactating female; blood or urine pregnancy test positive
19. Have a history of blood or Needles fainting, or difficulty in collecting blood
20. Unable to complete the study for other reasons or Researchers believe that those who should not be included;
21. Researchers and their relatives including spouses and children will be not allowed to participate in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low dose	Drug: ALA 5%; prepare 5% ALA solution, apply topically to the affected area for 1.5 hours, single dose
Experimental: High dose	Drug: ALA 10%; prepare 10% ALA solution, apply topically to the affected area for 3 hours, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2021
• Primary Completion (Actual): July 30, 2021
• Study Completion (Actual): December 6, 2021

Study Registration Dates

• First Submitted: August 1, 2019
• First Submitted That Met QC Criteria: August 1, 2019
• First Posted (Actual): August 5, 2019

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Acne vulgaris
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: F0014-ALA-201811

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No