Molluscum ContagiosumNCT04476186
The Effectiveness of Oral Acyclovir in the Treatment of Molluscum Contagiosum in Children
A study testing Acyclovir and KOH 10 % in people with Molluscum Contagiosum, run by Dalia Mahran at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Molluscum Contagiosum
- What is being tested?
- Acyclovir and KOH 10 %
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2020to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children (2 -16) years old with Molluscum contagiosum.
Who cannot join
- Molluscum contagiosum with Inflamed spot Known immune compromised children Molluscum lesion in the eye lid. Children with renal impairment.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Hamdy Gomaa
Asyut, New Assiut City, 71684
Hamdy Gomaa, 00201000882184, dhamdy2003@yahoo.com
About this study
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
Read the 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.
- Conditions
- Molluscum Contagiosum
- Being tested
- Acyclovir, KOH 10 %
- Medical subject headings
- Molluscum Contagiosum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcyclovirDrug
Also called Zovirax - Acyclovir
oral syrp
KOH 10 %Drug
Also called KOH
solution for local application
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Active comparator | 200 mg of oral acyclovir 5 timed per day for 5 days per week for maximum 1 month Receives: Drug: Acyclovir |
| controlled group | Placebo comparator | KOH 10 % solution local application with apiece of cotton 2 time per day maximum for 1 month Receives: Drug: KOH 10 % |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patient with complete clearance of all molluscum lesions.
we will measure the percentage of patient recovered from all lesion
Measured: 3 month for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start15 Jun 2020
- Primary completion29 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molluscum ContagiosumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalia Mahran
- Sponsor type
- University, hospital or other
- Collaborators
- assistant professor Ghada M. Khafagy, Dr. Marwa Diaaeldeen Abbass Hasan, Prof. Dr. Emad Taha Abd-Elahim Ebiad
- Responsible party
- Sponsor-investigator, Dalia Mahran, Assiut University
- Investigators
- Ghada Mahmoud, Assist Prof, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476186
- Sponsor's protocol ID
- site of study assiut U H
- Status last verified
- Jul 2020
- First submitted
- 6 Jul 2020
- Last updated
- 20 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Oral Acyclovir in the Treatment of Molluscum Contagiosum in Children
- ClinicalTrials.gov ID
- NCT04476186
- Acronym / sponsor ID
- site of study assiut U H
- Conditions
- Molluscum Contagiosum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Dalia MahranUniversity, hospital or other
- Collaborators
- assistant professor Ghada M. Khafagy, Dr. Marwa Diaaeldeen Abbass Hasan, Prof. Dr. Emad Taha Abd-Elahim Ebiad
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 29 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Active comparator | Drug: Acyclovir200 mg of oral acyclovir 5 timed per day for 5 days per week for maximum 1 month |
| controlled group | Placebo comparator | Drug: KOH 10 %KOH 10 % solution local application with apiece of cotton 2 time per day maximum for 1 month |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children (2 -16) years old with Molluscum contagiosum.
Key exclusion criteria (1 listed)
- Molluscum contagiosum with Inflamed spot Known immune compromised children Molluscum lesion in the eye lid. Children with renal impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcyclovirAlso: Zovirax - Acycloviroral syrp | Drug | treatment group |
| KOH 10 %Also: KOHsolution for local application | Drug | controlled group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ghada Mahmoud, Assist Prof principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acyclovir and KOH 10 % in people with Molluscum Contagiosum, run by Dalia Mahran at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hamdy Gomaa (00201000882184, dhamdy2003@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patient with complete clearance of all molluscum lesions. (time frame: 3 month for each participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2020.