- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04476186
The Effectiveness of Oral Acyclovir in the Treatment of Molluscum Contagiosum in Children
July 14, 2020 updated by: Dalia Mahran
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hamdy Gomaa
- Phone Number: 00201000882184
- Email: dhamdy2003@yahoo.com
Study Locations
-
-
New Assiut City
-
Assiut, New Assiut City, Egypt, 71684
- Recruiting
- Hamdy Gomaa
-
Contact:
- Hamdy Gomaa
- Phone Number: 00201000882184
- Email: dhamdy2003@yahoo.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: treatment group
200 mg of oral acyclovir 5 timed per day for 5 days per week for maximum 1 month
|
oral syrp
Other Names:
|
Placebo Comparator: controlled group
KOH 10 % solution local application with apiece of cotton 2 time per day maximum for 1 month
|
solution for local application
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The percentage of patient with complete clearance of all molluscum lesions.
Time Frame: 3 month for each participant
|
we will measure the percentage of patient recovered from all lesion
|
3 month for each participant
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ghada Mahmoud, Assist Prof, Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 2020
Primary Completion (Anticipated)
December 29, 2021
Study Completion (Anticipated)
December 30, 2021
Study Registration Dates
First Submitted
July 6, 2020
First Submitted That Met QC Criteria
July 14, 2020
First Posted (Actual)
July 20, 2020
Study Record Updates
Last Update Posted (Actual)
July 20, 2020
Last Update Submitted That Met QC Criteria
July 14, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- site of study assiut U H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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