Molluscum ContagiosumPhase 2/3EKOH-MOL 2008NCT01348386
Efficacy and Tolerance of Potassium Hydroxide (10% and 15%) in Molluscum Contagiosum
A Phase 2/3 study testing Hydroxide Potassium in people with Molluscum Contagiosum, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
BACKGROUND: Molluscum contagiosum is a non-serious children viral infection. Because of its natural history, being highly contagious and the aesthetic and psychotherapeutic effects of its treatment, the investigators intend to test the use of different concentrations of potassium hydroxide solution in the primary care… Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Molluscum Contagiosum
- What is being tested?
- Hydroxide Potassium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2010to Mar 2012
- Phase
- Phase 2/3
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Who are diagnosed with a molluscum contagiosum (MC) infection (clinical diagnosis).
- Who are between the ages of two and six.
- Whose parents or guardians have provided written informed consent for participation.
Who cannot join
- Immunocompromised patient (congenital or acquired).
- Patient has received other topical treatment within the last month.
- Patient has lesions on face, neck or genital area.
- Patient who, in the view of the attending physician, will not comply with treatment and/or scheduled visits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Tolerance of the Topical Application of Potassium Hydroxide (10% and 15%) in the Treatment of Molluscum Contagiosum
BACKGROUND:
Molluscum contagiosum is a non-serious children viral infection. Because of its natural history, being highly contagious and the aesthetic and psychotherapeutic effects of its treatment, the investigators intend to test the use of different concentrations of potassium hydroxide solution in the primary care setting.
Read more
METHODS:
A double blind, randomized clinical trial, in three groups of topic treatment is designed. The intended treatment consists on a daily application of potassium hydroxide in aqueous solution at 10% and 15% concentration, versus a placebo administered to the control group. 4 follow-up visits (15, 30, 45 and 60 days) are planned to evaluate treatment effectiveness and tolerance.
The main target of the trial is to determine the healing rate, defined as lesion disappearance in the affected zones after the topic application of the treatment. Secondary targets are the main characteristics and evolution of the affected zone (surface, number of lesions, size and density) description, tolerance evaluation (hyperpigmentation, itching, burning, pain), recurrence rate estimation and natural evolution of lesions in the control group.
- Conditions
- Molluscum Contagiosum
- Being tested
- Hydroxide Potassium, Placebo
- Keywords
- Potassium hydroxide., Molluscum Contagiosum
- Medical subject headings
- Molluscum Contagiosum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxide PotassiumDrug
Treatment will consist of the application of topical 10% or 15% KOH in an aqueous solution for the two treatment groups, compared to a placebo-treated control group. Topical Application.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| KOH 10% | Experimental | Treatment consists of the application of topical 10% KOH in an aqueous solution. Receives: Drug: Hydroxide Potassium |
| KOH 15% | Experimental | Treatment consists of the application of topical 15% KOH in an aqueous solution Receives: Drug: Hydroxide Potassium |
| PLACEBO | Placebo comparator | 100 milliliters of saline solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy (diseappearance of lesions)
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startMar 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348386
- Sponsor's protocol ID
- EC08/00011
- Acronym
- EKOH-MOL 2008
- Status last verified
- May 2011
- First submitted
- 4 May 2011
- Last updated
- 1 Oct 2015
- Results posted
- No
Publications
Marsal JR, Cruz I, Teixido C, Diez O, Martinez M, Galindo G, Real J, Schoenenberger JA, Pera H. Efficacy and tolerance of the topical application of potassium hydroxide (10% and 15%) in the treatment of molluscum contagiosum: randomized clinical trial: research protocol. BMC Infect Dis. 2011 Oct 19;11:278. doi: 10.1186/1471-2334-11-278.
PubMed 22011376
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerance of the Topical Application of Potassium Hydroxide (10% and 15%) in the Treatment of Molluscum Contagiosum
- ClinicalTrials.gov ID
- NCT01348386
- Acronym / sponsor ID
- EKOH-MOL 2008 / EC08/00011
- Conditions
- Molluscum Contagiosum
- Keywords
- Potassium hydroxide., Molluscum Contagiosum
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 5 May 2011 (estimated)
- 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.
BACKGROUND:
Molluscum contagiosum is a non-serious children viral infection. Because of its natural history, being highly contagious and the aesthetic and psychotherapeutic effects of its treatment, the investigators intend to test the use of different concentrations of potassium hydroxide solution in the primary care setting.
METHODS:
A double blind, randomized clinical trial, in three groups of topic treatment is designed. The intended treatment consists on a daily application of potassium hydroxide in aqueous solution at 10% and 15% concentration, versus a placebo administered to the control group. 4 follow-up visits (15, 30, 45 and 60 days) are planned to evaluate treatment effectiveness and tolerance.
The main target of the trial is to determine the healing rate, defined as lesion disappearance in the affected zones after the topic application of the treatment. Secondary targets are the main characteristics and evolution of the affected zone (surface, number of lesions, size and density) description, tolerance evaluation (hyperpigmentation, itching, burning, pain), recurrence rate estimation and natural evolution of lesions in the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| KOH 10% | Experimental | Drug: Hydroxide PotassiumTreatment consists of the application of topical 10% KOH in an aqueous solution. |
| KOH 15% | Experimental | Drug: Hydroxide PotassiumTreatment consists of the application of topical 15% KOH in an aqueous solution |
| PLACEBO | Placebo comparator | Drug: Placebo100 milliliters of saline solution |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Who are diagnosed with a molluscum contagiosum (MC) infection (clinical diagnosis).
- Who are between the ages of two and six.
- Whose parents or guardians have provided written informed consent for participation.
Key exclusion criteria (4 listed)
- Immunocompromised patient (congenital or acquired).
- Patient has received other topical treatment within the last month.
- Patient has lesions on face, neck or genital area.
- Patient who, in the view of the attending physician, will not comply with treatment and/or scheduled visits.
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 |
|---|---|---|
| Hydroxide PotassiumTreatment will consist of the application of topical 10% or 15% KOH in an aqueous solution for the two treatment groups, compared to a placebo-treated control group. Topical Application. | Drug | KOH 10%, KOH 15% |
| Placebo | Drug | PLACEBO |
Primary outcome
Efficacy (diseappearance of lesions)
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2015.
- Derived from this study: PubMed 22011376Marsal JR, Cruz I, Teixido C, Diez O, Martinez M, Galindo G, Real J, Schoenenberger JA, Pera H. Efficacy and tolerance of the topical application of potassium hydroxide (10% and 15%) in the treatment of molluscum contagiosum: randomized clinical trial: research protocol. BMC Infect Dis. 2011 Oct 19;11:278. doi: 10.1186/1471-2334-11-278.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Hydroxide Potassium in people with Molluscum Contagiosum, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 1 Oct 2015. 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 Spain. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (diseappearance of lesions) (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01348386, which also lists 1 linked publication.
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 1 Oct 2015.