Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 91 of 292 for:    acne AND moderate

A Pharmacokinetics and Safety Study of ALA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04044898
Recruitment Status : Not yet recruiting
First Posted : August 5, 2019
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Brief Summary:
To study the pharmacokinetic characteristics and safety of the ALA in patients with moderate and severe acne vulgaris after different dosages and single dose, and to understand the pharmacokinetic behavior of the drug and its active metabolite PpIX in human body, so as to provide a reference for the formulation of treatment plans in subsequent clinical trials.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: ALA Topical Powder Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pharmacokinetics and Safety Study of Aminolevulinic Acid Hydrochloride Topical Powder for the Treatment of Moderate to Severe Facial Acne Vulgaris.
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Low dose Drug: ALA Topical Powder
Use a moisturizing gel to prepare the drug in a 5% solution, apply topically to the affected area, single dose

Experimental: High dose Drug: ALA Topical Powder
Use a moisturizing gel to prepare the drug in a 10% solution, apply topically to the affected area, single dose




Primary Outcome Measures :
  1. Maximum Plasma Concentration [Cmax] [ Time Frame: 24 hours after dose ]
    pharmacokinetic parameter

  2. Area Under the Curve [AUC] [ Time Frame: 24 hours after dose ]
    pharmacokinetic parameter

  3. Tmax [ Time Frame: 24 hours after dose ]
    pharmacokinetic parameter

  4. Half-life Time [T1/2] [ Time Frame: 24 hours after dose ]
    pharmacokinetic parameter

  5. Clearance [CL] [ Time Frame: 24 hours after dose ]
    pharmacokinetic parameter

  6. Apparent Volume of Distribution [Vd] [ Time Frame: 24 hours after dose ]
    pharmacokinetic parameter

  7. Maximum Plasma Concentration [Cmax](after deduction of background) [ Time Frame: 24 hours after dose ]
    pharmacokinetic parameter

  8. Area Under the Curve [AUC](after deduction of background) [ Time Frame: 24 hours after dose ]
    pharmacokinetic parameter

  9. Tmax(after deduction of background) [ Time Frame: 24 hours after dose ]
    pharmacokinetic parameter

  10. Half-life Time [T1/2](after deduction of background) [ Time Frame: 24 hours after dose ]
    pharmacokinetic parameter

  11. Clearance [CL](after deduction of background) [ Time Frame: 24 hours after dose ]
    pharmacokinetic parameter

  12. Apparent Volume of Distribution [Vd](after deduction of background) [ Time Frame: 24 hours after dose ]
    pharmacokinetic parameter

  13. Incidence of adverse events [ Time Frame: Till 2 month after dose ]
  14. Incidence of laboratory abnormalities [ Time Frame: Till 2 month after dose ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Chinese male or female subjects between18 and 45 years (pre-study are male);
  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 within 14 days before the time of administration 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 commencement of administration;
  8. Severe external injuries were suffered within the first 3 months (90 days) before administration, or Patients who have undergone surgical treatment may significantly affect the process of studying drugs in vivo or safety assessment;
  9. Used clinical trial drugs within 3 months (90 days) before administration,or persons are participating in or plan to participate in other clinical trials during the study period.
  10. Drinked alcohol regularly within 3 months (90 days) before administration (≥3 times a week, and the average drink is equivalent to 50° white wine ≥200 mL) or persons can not be prohibited during the study, or alcohol breath test positive
  11. Smoked cigarettes within 3 months (90 days) before administration (more than 10 cigarettes or equivalent of tobacco per day) 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) before administration, 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) before administration;
  14. Drinks or food intake excessive of alcohol or caffeine (coffee, tea, cola, chocolate, etc.) within 48 hours before administration;
  15. Have a history of drug abuse or positive drug abuse screening;
  16. Hepatitis B surface antigen or hepatitis C virus antibodyor 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, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04044898


Contacts
Layout table for location contacts
Contact: Leihong Xiang, MD 0086-021-52887775 flora_xiang@vip.163.com
Contact: Jing Zhang, PhD 0086-021-52887926 Zhangj_fudan@163.com

Locations
Layout table for location information
China, Shanghai
Huashan Hospital
Shanghai, Shanghai, China, 200040
Sponsors and Collaborators
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Layout table for additonal information
Responsible Party: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT04044898     History of Changes
Other Study ID Numbers: F0014-ALA-201811
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.:
Acne vulgaris
Additional relevant MeSH terms:
Layout table for MeSH terms
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases