Ignite Creation Date:
2024-05-06 @ 10:34 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03290027
Status:
COMPLETED
Last Update Posted:
2021-03-01
First Post:
2017-09-19
Brief Title:
A Study of the Safety and Efficacy of DFD-03 for the Treatment of Acne Vulgaris
Sponsor:
Dr Reddys Laboratories Limited
Organization:
Dr Reddys Laboratories Limited
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Parallel-Group Vehicle-Controlled Study of the Safety and Efficacy of DFD-03 Lotion in the Treatment of Acne Vulgaris for 12 Weeks
Status:
COMPLETED
Status Verified Date:
2021-02
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:
DFD-03
Brief Summary:
Enrollment of subjects with mild to moderate facial acne Efficacy was assessed by using an Investigators Global Assessment scale IGA 5 point scale and by counting the number of inflammatory and non-inflammatory lesions on the face at Baseline and Weeks 4 8 and 12
Safety assessments included the investigators assessment of local cutaneous tolerance of the treated skin dryness non-lesional erythema peeling stinging burning and itching vital signs and adverse events AEs
Safety assessments included the investigators assessment of local cutaneous tolerance of the treated skin dryness non-lesional erythema peeling stinging burning and itching vital signs and adverse events AEs
Detailed Description:
Enrollment of subjects with mild to moderate facial acne Subjects with acne lesions of any severity on the chest andor back including shoulders were enrolled provided they had mild to moderate acne on the face During the 12-week treatment period subjects used the study product twice daily Subjects were instructed to treat the entire face and chest andor back including shoulders if applicable
Efficacy was assessed by using an Investigators Global Assessment scale IGA 5 point scale and by counting the number of inflammatory and non-inflammatory lesions on the face at Baseline and Weeks 4 8 and 12
Safety assessments included the investigators assessment of local cutaneous tolerance of the treated skin dryness non-lesional erythema peeling stinging burning and itching assessed separately on the chest andor back including shoulders if applicable vital signs blood pressure and pulse rate and adverse events AEs Urine pregnancy tests were performed at Baseline and at every visit through Week 12 for all female subjects A physical examination was performed
Efficacy was assessed by using an Investigators Global Assessment scale IGA 5 point scale and by counting the number of inflammatory and non-inflammatory lesions on the face at Baseline and Weeks 4 8 and 12
Safety assessments included the investigators assessment of local cutaneous tolerance of the treated skin dryness non-lesional erythema peeling stinging burning and itching assessed separately on the chest andor back including shoulders if applicable vital signs blood pressure and pulse rate and adverse events AEs Urine pregnancy tests were performed at Baseline and at every visit through Week 12 for all female subjects A physical examination was performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None