NCT04476186

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2020

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 20, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

July 20, 2020

Status Verified

July 1, 2020

Enrollment Period

1.5 years

First QC Date

July 6, 2020

Last Update Submit

July 14, 2020

Conditions

Molluscum Contagiosum

Outcome Measures

Primary Outcomes (1)

  • The percentage of patient with complete clearance of all molluscum lesions.

    we will measure the percentage of patient recovered from all lesion

    3 month for each participant

Study Arms (2)

treatment group

ACTIVE COMPARATOR

200 mg of oral acyclovir 5 timed per day for 5 days per week for maximum 1 month

Drug: Acyclovir

controlled group

PLACEBO COMPARATOR

KOH 10 % solution local application with apiece of cotton 2 time per day maximum for 1 month

Drug: KOH 10 %

Interventions

AcyclovirDRUG

oral syrp

Also known as: Zovirax - Acyclovir
treatment group
KOH 10 %DRUG

solution for local application

Also known as: KOH
controlled group

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children (2 -16) years old with Molluscum contagiosum.

You may not qualify if:

  • Molluscum contagiosum with Inflamed spot Known immune compromised children Molluscum lesion in the eye lid. Children with renal impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamdy Gomaa

Asyut, New Assiut City, 71684, Egypt

RECRUITING

MeSH Terms

Conditions

Molluscum Contagiosum

Interventions

Acyclovir

Condition Hierarchy (Ancestors)

Poxviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Ghada Mahmoud, Assist Prof

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hamdy Gomaa

CONTACT

00201000882184dhamdy2003@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor of public health and community medicine

Study Record Dates

First Submitted

July 6, 2020

First Posted

July 20, 2020

Study Start

June 15, 2020

Primary Completion

December 29, 2021

Study Completion

December 30, 2021

Last Updated

July 20, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)