Ignite Creation Date:
2024-05-06 @ 1:59 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01948570
Status:
COMPLETED
Last Update Posted:
2017-09-01
First Post:
2013-09-06
Brief Title:
Clinical Study for the Evaluation of P-3075 Cream on Acne Treatment
Sponsor:
Derming SRL
Organization:
Derming SRL
Study Overview
Official Title:
Clinical Study for the Evaluation of P-3075 Cream on Acne Treatment
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ANTI-ACNE
Brief Summary:
Primary end point of the study is the clinical and non-invasive instrumental evaluation of the activity of P-3075 cream on subjects with acne 20 subjects with a mildmoderate grade and 20 subjects with a moderately severesevere grade according to Cunliffe classification
Secondary end-points are the cosmetic acceptability and efficacy evaluation by the volunteers and the local tolerability assessed by the investigator and the subjects
Secondary end-points are the cosmetic acceptability and efficacy evaluation by the volunteers and the local tolerability assessed by the investigator and the subjects
Detailed Description:
This is an open controlled clinical trial The product will be applied for a period of 4 weeks and 3 visits will be performed a baseline visit T0 an intermediate visit after 2 weeks T2 and a final visit after 4 week-treatment T4
The subjects will be enrolled and divided in 2 groups according to their acne grade 20 subjects with mildmoderate grade and 20 subjects with moderately severesevere a concomitant therapy is allowed only for volunteers with acne moderately severesevere
Each volunteer fulfilling the inclusion criteria will perform a cosmetic treatment with the study product on all the face for 4 weeks
A fixed quantity of the medical device will be applied on the face twice a day in the morning and in the evening always at the same hour with a mild massage according to the instructions received by the investigator during the baseline visit T0 Group 2 will continue also the standardised treatment with topical or systemic retinoids benzoyl peroxide clindamycin or AHA until the end of the study
The subjects will be enrolled and divided in 2 groups according to their acne grade 20 subjects with mildmoderate grade and 20 subjects with moderately severesevere a concomitant therapy is allowed only for volunteers with acne moderately severesevere
Each volunteer fulfilling the inclusion criteria will perform a cosmetic treatment with the study product on all the face for 4 weeks
A fixed quantity of the medical device will be applied on the face twice a day in the morning and in the evening always at the same hour with a mild massage according to the instructions received by the investigator during the baseline visit T0 Group 2 will continue also the standardised treatment with topical or systemic retinoids benzoyl peroxide clindamycin or AHA until the end of the study
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