mild to moderate acne vulgaris
Conditions
Interventions
Ia-1st Cohort:5% BSA 8mg PD-DP-008 / 8g PD-DP-008 Gel/Placebo
Ia-2nd Cohort:10% BSA 16mg PD-DP-008 / 16g PD-DP-008 Gel/Placebo
Ia-3rd Cohort:15% BSA 24mg PD-DP-008 / 24g PD-DP-008 Gel/Placebo
Ia-4th Cohort:15% BSA 48mg PD-DP-008 / 48g PD-DP-008 Gel/Placebo
Ib-Treatment Group:0.1% PD-DP-008
Ib-Placebo Group:0.1% PD-DP-008
Sponsors
Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Subjects should meet all the following inclusion criteria before they can be included in this study: 1. Fully understand the purpose, nature, methods and possible adverse reactions of the trial, and voluntarily sign the informed consent; 2. The age is 18-45 years old (including the boundary value, based on the time when the informed consent form was signed), both men and women are acceptable; 3. Body Mass Index (BMI) is in the range of 19~26 kg/m2 (including boundary value), and the weight of men is not less than 50 kg and that of women is not less than 45 kg; 4. According to the medical history, physical examination, vital signs, 12-lead ECG examination, laboratory examination (blood routine test, urine routine test, blood biochemistry test , blood coagulation function test), serum virology and chest X-ray, the investigator judged that the overall health status of the subjects was good (whether the examination results were normal or abnormal had no clinical significance). Patients with acne in the second part also need to meet the following inclusion criteria: 5. Patients clinically diagnosed as mild to moderate acne vulgaris (refer to China acne treatment guidelines, revised edition in 2019) are classified as I-III according to the international improved classification of Pillsbury classification, and scored as 2-3 points by IGA (see IGA score in Appendix 1 for the IGA scale).
Exclusion criteria
Exclusion criteria: Participants with any of the following exclusion criteria shall not be included in this trial: 1. Participants who have diseases or factors with abnormal clinical manifestations that investigators think are not suitable to participate in this study. 2. Those who have a history of drug abuse in the past five years or used drugs in the three months before screening, or who have been screened positive for drug abuse in the screening period and/or the baseline period; 3. Those who smoke more than 5 cigarettes a day or habitually use nicotine-containing products within 3 months before screening; 4. Those who drink more than 14 units of alcohol per week in the first 3 months of screening, or have taken alcoholic products 48 hours before receiving the test drug, or have a positive breath test for alcohol at baseline; 5. Participants who have undergone major surgery within 28 days before taking the drug for the first time, or who have a history of surgery judged by the investigator to be clinically significant, or who are expected to need major surgery during the trial; 6. Participants with other obvious skin diseases that may affect the efficacy and safety evaluation (such as solar dermatitis, hormone-dependent dermatitis, rose acne's disease, psoriasis, seborrheic dermatitis, eczema, etc.); 7. Oral administration or injection of any medicine (including therapeutic vitamins or vitamin supplements) for various reasons within 4 weeks before taking the medicine for the first time, and the time has not reached the five half-lives of the medicine used; 8. Ingesting any food or beverage (such as coffee, tea, chocolate) containing caffeine or xanthine after metabolism within 48 hours before the first dosing; 9. Those who have been vaccinated within 14 days before the first medication, or plan to be vaccinated with live or attenuated vaccines during the study period or within 1 week after the end of the study; 10. Participants who have been exposed to excessive or long-term sunlight or extreme weather (such as wind or cold); 11. Participated in other clinical trials of drugs and used other clinical trials within 3 months before the first dosing; 12. Those who have donated blood or lost more than 400 mL in the 3 months before screening; 13.Unprotected sex occurred within 14 days before screening, or pregnancy test was positive during screening/baseline period or was in Lactating female subjects; Plan pregnancy and feeding during the trial and within 3 months after the last administration.Lactating female subjects or male subjects who plan to donate sperm, as well as during the trial and the last administration.Can't take reliable contraceptive measures within the last 3 months (see Appendix 2 for contraceptive measures and requirements).Contraceptive measures and the definition of women of childbearing age); 14. Any other investigator thinks that it may affect the subjects' informed consent or compliance with the test plan, or the subjects' participation in the trial may affect the test results or their own safety, or the subjects are unwilling to participate in the study for personal reasons; 15. For healthy subjects (phase Ia): the subjects who plan to use various skin care products at the same time at the medication site during the trial. In the second part, acne patients who meet any of the following exclusion criteria are not allowed to enter the group: 16. Too dense hair on the face (such as beard and sideburns) may interfere with the diagnosis a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event/Serious Adverse Event;Vital Sign;Laboratory examination (three routine tests and blood coagulation function);12-lead electrocardiogram;Local tolerance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenic endpoint;Pharmacokinetic result;Changes of inflammatory skin lesion count from baseline;Changes of noninflammatory skin lesion count from baseline;Improvement of IGA grading compared with baseline; | — |
Countries
China
Contacts
Public ContactJi Li/ Gan Zhou
Xiangya Hospital of Central South University
Outcome results
None listed