Tinea CapitisPhase 2NCT02658292
Safety and Efficacy of NAFT900 in Children With Tinea Capitis
A Phase 2 study testing Naftifine hydrochloride foam, 3% in people with Tinea Capitis, run by Merz North America, Inc..
Trial summary
A Double-Blind, Randomized, Vehicle-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of NAFT-900 in Children Aged 6 to < 13 Years with Tinea Capitis Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Tinea Capitis
- What is being tested?
- Naftifine hydrochloride foam, 3%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Jul 2016
- Phase
- Phase 2
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects with clinical diagnosis of tinea capitis with ≤15% involvement of the scalp.
- Subjects with positive KOH microscopy and culture [for dermatophytes].
- Male or female subjects ≥6 years and <13 years of age on the date of the Baseline Visit.
Who cannot join
- Subject with acute inflammatory fungal infection of the scalp (kerion)
- Subjects with skin disease on the scalp, or any other condition or prior/present treatment which in the opinion of the investigator would interfere with the study drug's effect or assessments (e.g., psoriasis, seborrheic dermatitis).
- Subjects who received immunosuppressant therapy, cytostatic therapy or radiation therapy within 4 weeks prior to the baseline.
- Subjects who received systemic corticosteroids and/or systemic antibiotics within 4 weeks prior to study entry (or during study).
- Subjects who have used systemic antifungal treatment within 4 weeks prior to the baseline.
- Subjects who have used antifungal agents, corticosteroid preparations, ketoconazole, ciclopirox, salicylic acid, terbinafine, amorolfine, butenafine, clotrimazole, econazole, oxiconazole, sertaconazole, sulconazole, luliconazole, fluconazole, benzoic acid, griseofulvin, undecylenic acid, zinc pyrithione or selenium sulfide, or tar containing topical treatments for their scalp within 1 week prior to the baseline visit.
- Subjects with a life-threatening condition (ex. autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months prior to baseline visit.
About this study
Official title: A Double-Blind, Randomized, Vehicle-Control, Multicenter Study to Evaluate the Efficacy and Safety of NAFT900 in Children With Tinea Capitis Aged 6 to < 13 Years
A Double-Blind, Randomized, Vehicle-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of NAFT-900 in Children Aged 6 to < 13 Years with Tinea Capitis
Read the detailed description
This is an 8-week double-blind, randomized, vehicle-controlled, multicenter study of NAFT-900 compared to vehicle in the treatment of tinea capitis in children ≥6 years to <13 years of age.
There will be approximately 60 subjects enrolled. Qualifying subjects with clinical evidence of a tinea capitis infection involving ≤ 15% of the scalp, confirmed by positive culture, will be randomized 2:1 to one of the following treatments:
- NAFT-900 (Naftifine hydrochloride foam, 3%)
- Vehicle Foam The study will consist of up to 6 visits. Subjects will apply the assigned study product twice daily to the affected area(s) for 4 weeks
- Conditions
- Tinea Capitis
- Being tested
- Naftifine hydrochloride foam, 3%, Vehicle
- Keywords
- fungus, antifungal, skin infection, hair infection, dermatophyte, scalp, skin, eyebrows, eyelashes, hair, Trichophyton, Microsporum, Endothrix, spores
- Medical subject headings
- Tinea Capitis, Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naftifine hydrochloride foam, 3%Drug
Also called NAFT900
Apply NAFT900 foam twice daily to the affected area(s) plus half-inch around each affected area for 4 weeks
VehicleDrug
Also called Vehicle Foam
Apply vehicle foam twice daily to the affected area(s) plus half-inch around each affected area for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| NAFT900 | Active comparator | NAFT900 (Naftifine hydrochloride foam, 3%) Receives: Drug: Naftifine hydrochloride foam, 3% |
| Vehicle | Placebo comparator | Vehicle Foam Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the proportion of subjects with complete cure
Complete cure defined as negative KOH microscopy, negative dermatophyte culture and a score of 0 on baseline signs
Measured: 8 weeks
Secondary outcomes (2)
Compare the proportion of subjects with an effective treatment
Effective treatment is defined as negative KOH microscopy, negative dermatophyte culture and a score of 0 or 1 on baseline signs
Measured: 8 weeks
Compare the proportion of subjects with mycological cure
Mycological cure is defined as complete cure defined as negative KOH microscopy and negative dermatophyte culture
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Primary completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinea CapitisStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Kuligowski, MD, Study director, Merz North America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658292
- Sponsor's protocol ID
- M902001001
- Status last verified
- Sep 2016
- First submitted
- 12 Jan 2016
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Vehicle-Control, Multicenter Study to Evaluate the Efficacy and Safety of NAFT900 in Children With Tinea Capitis Aged 6 to < 13 Years
- ClinicalTrials.gov ID
- NCT02658292
- Acronym / sponsor ID
- M902001001
- Conditions
- Tinea Capitis
- Keywords
- fungus, antifungal, skin infection, hair infection, dermatophyte, scalp, skin, eyebrows
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Primary completion
- Jul 2016 (actual)
- First posted
- 18 Jan 2016 (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.
A Double-Blind, Randomized, Vehicle-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of NAFT-900 in Children Aged 6 to < 13 Years with Tinea Capitis
Detailed description
This is an 8-week double-blind, randomized, vehicle-controlled, multicenter study of NAFT-900 compared to vehicle in the treatment of tinea capitis in children ≥6 years to <13 years of age.
There will be approximately 60 subjects enrolled. Qualifying subjects with clinical evidence of a tinea capitis infection involving ≤ 15% of the scalp, confirmed by positive culture, will be randomized 2:1 to one of the following treatments:
- NAFT-900 (Naftifine hydrochloride foam, 3%)
- Vehicle Foam The study will consist of up to 6 visits. Subjects will apply the assigned study product twice daily to the affected area(s) for 4 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAFT900 | Active comparator | Drug: Naftifine hydrochloride foam, 3%NAFT900 (Naftifine hydrochloride foam, 3%) |
| Vehicle | Placebo comparator | Drug: VehicleVehicle Foam |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Subjects with clinical diagnosis of tinea capitis with ≤15% involvement of the scalp.
- Subjects with positive KOH microscopy and culture [for dermatophytes].
- Male or female subjects ≥6 years and <13 years of age on the date of the Baseline Visit.
Key exclusion criteria (7 listed)
- Subject with acute inflammatory fungal infection of the scalp (kerion)
- Subjects with skin disease on the scalp, or any other condition or prior/present treatment which in the opinion of the investigator would interfere with the study drug's effect or assessments (e.g., psoriasis, seborrheic dermatitis).
- Subjects who received immunosuppressant therapy, cytostatic therapy or radiation therapy within 4 weeks prior to the baseline.
- Subjects who received systemic corticosteroids and/or systemic antibiotics within 4 weeks prior to study entry (or during study).
- Subjects who have used systemic antifungal treatment within 4 weeks prior to the baseline.
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 |
|---|---|---|
| Naftifine hydrochloride foam, 3%Also: NAFT900Apply NAFT900 foam twice daily to the affected area(s) plus half-inch around each affected area for 4 weeks | Drug | NAFT900 |
| VehicleAlso: Vehicle FoamApply vehicle foam twice daily to the affected area(s) plus half-inch around each affected area for 4 weeks | Drug | Vehicle |
Primary outcome
Compare the proportion of subjects with complete cure
Time frame: 8 weeks
Complete cure defined as negative KOH microscopy, negative dermatophyte culture and a score of 0 on baseline signs
2 secondary outcomes
Compare the proportion of subjects with an effective treatment
Time frame: 8 weeks
Compare the proportion of subjects with mycological cure
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
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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.
Michael Kuligowski, MD study director
Merz North America, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Naftifine hydrochloride foam, 3% in people with Tinea Capitis, run by Merz North America, Inc..
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 7 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: withdrawn, as of the sponsor's last update on 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
Compare the proportion of subjects with complete cure (time frame: 8 weeks). 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 9 Sep 2016.