Ignite Creation Date:
2024-05-05 @ 11:30 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01348386
Status:
COMPLETED
Last Update Posted:
2015-10-01
First Post:
2011-05-04
Brief Title:
Efficacy and Tolerance of Potassium Hydroxide 10 and 15 in Molluscum Contagiosum
Sponsor:
Fundacio dInvestigacio en Atencio Primaria Jordi Gol i Gurina
Organization:
Fundacio dInvestigacio en Atencio Primaria Jordi Gol i Gurina
Study Overview
Official Title:
Efficacy and Tolerance of the Topical Application of Potassium Hydroxide 10 and 15 in the Treatment of Molluscum Contagiosum
Status:
COMPLETED
Status Verified Date:
2011-05
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:
EKOH-MOL 2008
Brief Summary:
BACKGROUND
Molluscum contagiosum is a non-serious children viral infection Because of its natural history being highly contagious and the aesthetic and psychotherapeutic effects of its treatment the investigators intend to test the use of different concentrations of potassium hydroxide solution in the primary care setting
METHODS
A double blind randomized clinical trial in three groups of topic treatment is designed The intended treatment consists on a daily application of potassium hydroxide in aqueous solution at 10 and 15 concentration versus a placebo administered to the control group 4 follow-up visits 15 30 45 and 60 days are planned to evaluate treatment effectiveness and tolerance
The main target of the trial is to determine the healing rate defined as lesion disappearance in the affected zones after the topic application of the treatment Secondary targets are the main characteristics and evolution of the affected zone surface number of lesions size and density description tolerance evaluation hyperpigmentation itching burning pain recurrence rate estimation and natural evolution of lesions in the control group
Molluscum contagiosum is a non-serious children viral infection Because of its natural history being highly contagious and the aesthetic and psychotherapeutic effects of its treatment the investigators intend to test the use of different concentrations of potassium hydroxide solution in the primary care setting
METHODS
A double blind randomized clinical trial in three groups of topic treatment is designed The intended treatment consists on a daily application of potassium hydroxide in aqueous solution at 10 and 15 concentration versus a placebo administered to the control group 4 follow-up visits 15 30 45 and 60 days are planned to evaluate treatment effectiveness and tolerance
The main target of the trial is to determine the healing rate defined as lesion disappearance in the affected zones after the topic application of the treatment Secondary targets are the main characteristics and evolution of the affected zone surface number of lesions size and density description tolerance evaluation hyperpigmentation itching burning pain recurrence rate estimation and natural evolution of lesions in the control group
Detailed Description:
None
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