The Effectiveness of Oral Acyclovir in the Treatment of Molluscum Contagiosum in Children
Primary Purpose
Molluscum Contagiosum
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Acyclovir
KOH 10 %
Sponsored by
About this trial
This is an interventional treatment trial for Molluscum Contagiosum
Eligibility Criteria
Inclusion Criteria:
- Children (2 -16) years old with Molluscum contagiosum.
Exclusion Criteria:
- Molluscum contagiosum with Inflamed spot Known immune compromised children Molluscum lesion in the eye lid. Children with renal impairment.
Sites / Locations
- Hamdy GomaaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
treatment group
controlled group
Arm Description
200 mg of oral acyclovir 5 timed per day for 5 days per week for maximum 1 month
KOH 10 % solution local application with apiece of cotton 2 time per day maximum for 1 month
Outcomes
Primary Outcome Measures
The percentage of patient with complete clearance of all molluscum lesions.
we will measure the percentage of patient recovered from all lesion
Secondary Outcome Measures
Full Information
NCT ID
NCT04476186
First Posted
July 6, 2020
Last Updated
July 14, 2020
Sponsor
Dalia Mahran
Collaborators
assistant professor Ghada M. Khafagy, Dr. Marwa Diaaeldeen Abbass Hasan, Prof. Dr. Emad Taha Abd-Elahim Ebiad
1. Study Identification
Unique Protocol Identification Number
NCT04476186
Brief Title
The Effectiveness of Oral Acyclovir in the Treatment of Molluscum Contagiosum in Children
Official Title
The Effectiveness of Oral Acyclovir in the Treatment of Molluscum Contagiosum in Children
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
December 29, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dalia Mahran
Collaborators
assistant professor Ghada M. Khafagy, Dr. Marwa Diaaeldeen Abbass Hasan, Prof. Dr. Emad Taha Abd-Elahim Ebiad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators will study the effectiveness of acyclovir in the treatment of molluscum contagiosum in assiut university hospital - dermatological out patient clinic the treatment group will receive acyclovir 200 mg 5 times per day the controlled group will receive local KOH solution
Detailed Description
Study population:
Site of the study: The outpatient dermatological clinic in Assiut university hospital.
Participants: children (2 -16) years' old attending dermatological clinic in Assiut university hospital and their parents.
Methodology in details:
We will use the social media as " Facebook" to invite patient to visit the clinic and follow up them due to the protective measures of covid 19.
Diagnosis of the patient with molluscum contagiosum according to the clinical picture
Collecting data including personal and clinical data through interviewing the patient and his or her parents
Pictures of the lesions will be taken before and after treatment after patient consent.
We will Randomly assigning the patient to either treatment group or controlled group according to simple random table
Prescribing the treatment according to the patient group
Follow up of the patient after 1 weak and each week according to the response to treatment or presence of complication
Inclusion criteria:
Children (5 -15) years old with Molluscum contagiosum.
Exclusion criteria:
Molluscum contagiosum with Inflamed spot
Known immune compromised children
Molluscum lesion in the eye lid.
Children with renal impairment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Molluscum Contagiosum
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Active Comparator
Arm Description
200 mg of oral acyclovir 5 timed per day for 5 days per week for maximum 1 month
Arm Title
controlled group
Arm Type
Placebo Comparator
Arm Description
KOH 10 % solution local application with apiece of cotton 2 time per day maximum for 1 month
Intervention Type
Drug
Intervention Name(s)
Acyclovir
Other Intervention Name(s)
Zovirax - Acyclovir
Intervention Description
oral syrp
Intervention Type
Drug
Intervention Name(s)
KOH 10 %
Other Intervention Name(s)
KOH
Intervention Description
solution for local application
Primary Outcome Measure Information:
Title
The percentage of patient with complete clearance of all molluscum lesions.
Description
we will measure the percentage of patient recovered from all lesion
Time Frame
3 month for each participant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children (2 -16) years old with Molluscum contagiosum.
Exclusion Criteria:
Molluscum contagiosum with Inflamed spot Known immune compromised children Molluscum lesion in the eye lid. Children with renal impairment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hamdy Gomaa
Phone
00201000882184
Email
dhamdy2003@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ghada Mahmoud, Assist Prof
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamdy Gomaa
City
Assiut
State/Province
New Assiut City
ZIP/Postal Code
71684
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hamdy Gomaa
Phone
00201000882184
Email
dhamdy2003@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effectiveness of Oral Acyclovir in the Treatment of Molluscum Contagiosum in Children
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