Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06587685
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
A Study to Assess the Efficacy and Safety of PG-011 Gel in Adolescents and Adults With Atopic Dermatitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Clinical Study to Assess the Efficacy and Safety of PG-011 Gel With 8 Weeks Treatment and Extension Safety Study to 52 Weeks in Adolescents and Adults With Atopic Dermatitis
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Multicenter Randomized Double-blind Placebo-controlled seamless and adaptive-designed phase IIbIII study to Assess the Efficacy and Safety of topical use of PG-011 Gel in adolescents and Adults With Atopic Dermatitis It consists of phase IIb and phase III parts phase IIb is a dose-ranging part and has been done and phase III is a pivotal study part which is registered this time
The goal of this phase III clinical trial is to learn if PG-011gel works to treat mild to moderate Atopic Dermatitis in adolescents and adults by topical use It will also learn about the safety of PG-011gel Investigators will compare PG-011gel to a placebo a look-alike substance that contains no drug to see if PG-011gel works to treat mild to moderate Atopic Dermatitis
Participants will
Use PG-011gel or a placebo twice daily for initial 8 weeks and followed by using PG-011 gel for all of the participants till 52-week
Visit the clinic at weeks 1 2 4 and 8 for checkups and tests and followed by visiting the clinic every 4 weeks till 52-week
Keep a diary of their symptoms
The goal of this phase III clinical trial is to learn if PG-011gel works to treat mild to moderate Atopic Dermatitis in adolescents and adults by topical use It will also learn about the safety of PG-011gel Investigators will compare PG-011gel to a placebo a look-alike substance that contains no drug to see if PG-011gel works to treat mild to moderate Atopic Dermatitis
Participants will
Use PG-011gel or a placebo twice daily for initial 8 weeks and followed by using PG-011 gel for all of the participants till 52-week
Visit the clinic at weeks 1 2 4 and 8 for checkups and tests and followed by visiting the clinic every 4 weeks till 52-week
Keep a diary of their symptoms
Detailed Description:
This is a randomized double-blind placebo-controlled multicenter clinical trial in adolescent and adult participants aged from 12 to 75 years old including threshold with mild to moderate Atopic Dermatitis Approximately 472 participants will be randomized 31 to PG-011 gel 3 BID or placebo gel In addition approximately 10 of the overall study population will consist of adolescents Participants with AD involvement of 3 to 20 BSA and IGA score of 2 to 3 will receive blinded study treatment for 8 weeks followed by an open-label treatment for 44 weeks at last the safety follow-up for 2 weeks
The study is to evaluate the efficacy and long-term safety of PG-011 gel 3 in the treatment of mild to moderate Atopic Dermatitis and the PK characteristics by sparse sampling
The study is to evaluate the efficacy and long-term safety of PG-011 gel 3 in the treatment of mild to moderate Atopic Dermatitis and the PK characteristics by sparse sampling
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None