Clincosm LogoSign in Get a demo

The Effectiveness of Oral Acyclovir in the Treatment of Molluscum Contagiosum in Children

Sponsor
Dalia Mahran (Other)
Overall Status
Unknown status
CT.gov ID
NCT04476186
Collaborator
assistant professor Ghada M. Khafagy (Other), Dr. Marwa Diaaeldeen Abbass Hasan (Other), Prof. Dr. Emad Taha Abd-Elahim Ebiad (Other)
35
Enrollment
1
Location
2
Arms
18.5
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
35 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Effectiveness of Oral Acyclovir in the Treatment of Molluscum Contagiosum in Children
Actual Study Start Date :
Jun 15, 2020
Anticipated Primary Completion Date :
Dec 29, 2021
Anticipated Study Completion Date :
Dec 30, 2021

Arms and Interventions

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

Drug: Acyclovir
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

    Drug: KOH 10 %
    solution for local application
    Other Names:
  • KOH

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The percentage of patient with complete clearance of all molluscum lesions. [3 month for each participant]

      we will measure the percentage of patient recovered from all lesion

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hamdy Gomaa Assiut New Assiut City Egypt 71684

    Sponsors and Collaborators

    • Dalia Mahran
    • assistant professor Ghada M. Khafagy
    • Dr. Marwa Diaaeldeen Abbass Hasan
    • Prof. Dr. Emad Taha Abd-Elahim Ebiad

    Investigators

    • Principal Investigator: Ghada Mahmoud, Assist Prof, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dalia Mahran, professor of public health and community medicine, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04476186
    Other Study ID Numbers:
    • site of study assiut U H
    First Posted:
    Jul 20, 2020
    Last Update Posted:
    Jul 20, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Molluscum Contagiosum
    Acyclovir

    Study Results

    No Results Posted as of Jul 20, 2020