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

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:

  1. 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.
  2. Diagnosis of the patient with molluscum contagiosum according to the clinical picture
  3. Collecting data including personal and clinical data through interviewing the patient and his or her parents
  4. Pictures of the lesions will be taken before and after treatment after patient consent.
  5. We will Randomly assigning the patient to either treatment group or controlled group according to simple random table
  6. Prescribing the treatment according to the patient group
  7. 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:

  1. Molluscum contagiosum with Inflamed spot
  2. Known immune compromised children
  3. Molluscum lesion in the eye lid.
  4. 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

Study Locations

    • New Assiut City
      • Assiut, New Assiut City, Egypt, 71684
        • Recruiting
        • Hamdy Gomaa
        • Contact:

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:
  • Zovirax - Acyclovir
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:
  • KOH

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

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

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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