Tinea CapitisPhase 3NCT00117767
Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
A Phase 3 study testing Terbinafine hydrochloride (HCl) and Griseofulvin in people with Tinea Capitis, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
Tinea capitis is a dermatophyte infection of the scalp hair follicles, which occurs primarily in children. Hair loss, hair breakage, scaling, plus various degrees of erythema, pustules and pruritus are the primary clinical signs which can be associated with tinea capitis. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Tinea Capitis
- What is being tested?
- Terbinafine hydrochloride (HCl) and Griseofulvin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Mar 2006
- Phase
- Phase 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with clinical diagnosis of tinea capitis confirmed by positive KOH determined by the central mycology laboratory.
- Male or female patients who are at least 4 years old and no more than 12 years old.
Who cannot join
- Patients having a medical condition that alters the absorption and/or metabolism of terbinafine (e.g. liver, renal disease etc.)
- Patients receiving medication that may interfere with the evaluation of the drug's effect
- Patients who have kerions requiring immediate treatment or treatment with systemic corticosteroids and/or systemic antibiotics
- Patients with a history of liver disease or current/active liver disease or with elevation of livery enzymes outside of the normal range corresponding to their age
- Patients who have received recent systemic or topical treatment for tinea capitis within the specified time periods (e.g. systemic antifungals within 2 months of screening visit, topical treatments [e.g. antifungals, corticosteroid preparations, zinc pyrithione or selenium sulfide or tar containing products] within 1 week of screening).
- Patients with a history of systemic lupus erythematosus
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936
About this study
Official title: Efficacy and Safety of Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
Tinea capitis is a dermatophyte infection of the scalp hair follicles, which occurs primarily in children. Hair loss, hair breakage, scaling, plus various degrees of erythema, pustules and pruritus are the primary clinical signs which can be associated with tinea capitis. The infection is caused by a relatively small group of dermatophytes in the genera Trichophyton and Microsporum.
Terbinafine hydrochloride is a synthetic allylamine derivative antifungal agent. This study will evaluate the efficacy and safety of terbinafine in children with tinea capitis.
- Conditions
- Tinea Capitis
- Being tested
- Terbinafine hydrochloride (HCl), Griseofulvin
- Keywords
- Terbinafine, Tinea capitis, pediatric, antifungal
- Medical subject headings
- Tinea Capitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terbinafine hydrochloride (HCl)Drug
Also called Lamisil
Terbinafine hydrochloride (HCl) pediatric formulation (minitablets)o.d. administration
GriseofulvinDrug
Also called Grilfulvin V
Griseofulvin pediatric suspension o.d. administration
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Terbinafine Receives: Drug: Terbinafine hydrochloride (HCl) |
| 2 | Active comparator | Griseofulvin Receives: Drug: Griseofulvin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete cure (negative mycology and clinical cure) rate at Week 10
Secondary outcomes (3)
Clinical cure rate at Week 10
Mycological cure rate at Week 10
Safety of terbinafine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2005 (estimated)
- Study startJun 2004
- Primary completionMar 2006
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 Tinea CapitisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 720 participants
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00117767
- Sponsor's protocol ID
- CSFO327C2301
- Status last verified
- May 2017
- First submitted
- 30 Jun 2005
- Last updated
- 31 May 2017
- Results posted
- No
Publications
Elewski BE, Caceres HW, DeLeon L, El Shimy S, Hunter JA, Korotkiy N, Rachesky IJ, Sanchez-Bal V, Todd G, Wraith L, Cai B, Tavakkol A, Bakshi R, Nyirady J, Friedlander SF. Terbinafine hydrochloride oral granules versus oral griseofulvin suspension in children with tinea capitis: results of two randomized, investigator-blinded, multicenter, international, controlled trials. J Am Acad Dermatol. 2008 Jul;59(1):41-54. doi: 10.1016/j.jaad.2008.02.019. Epub 2008 Apr 18.
PubMed 18378354
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
- ClinicalTrials.gov ID
- NCT00117767
- Acronym / sponsor ID
- CSFO327C2301
- Conditions
- Tinea Capitis
- Keywords
- Terbinafine, Tinea capitis, pediatric, antifungal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720 participants
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Mar 2006 (actual)
- First posted
- 8 Jul 2005 (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.
Tinea capitis is a dermatophyte infection of the scalp hair follicles, which occurs primarily in children. Hair loss, hair breakage, scaling, plus various degrees of erythema, pustules and pruritus are the primary clinical signs which can be associated with tinea capitis. The infection is caused by a relatively small group of dermatophytes in the genera Trichophyton and Microsporum.
Terbinafine hydrochloride is a synthetic allylamine derivative antifungal agent. This study will evaluate the efficacy and safety of terbinafine in children with tinea capitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Terbinafine hydrochloride (HCl)Terbinafine |
| 2 | Active comparator | Drug: GriseofulvinGriseofulvin |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients with clinical diagnosis of tinea capitis confirmed by positive KOH determined by the central mycology laboratory.
- Male or female patients who are at least 4 years old and no more than 12 years old.
Key exclusion criteria (6 listed)
- Patients having a medical condition that alters the absorption and/or metabolism of terbinafine (e.g. liver, renal disease etc.)
- Patients receiving medication that may interfere with the evaluation of the drug's effect
- Patients who have kerions requiring immediate treatment or treatment with systemic corticosteroids and/or systemic antibiotics
- Patients with a history of liver disease or current/active liver disease or with elevation of livery enzymes outside of the normal range corresponding to their age
- Patients who have received recent systemic or topical treatment for tinea capitis within the specified time periods (e.g. systemic antifungals within 2 months of screening visit, topical treatments [e.g. antifungals, corticosteroid preparations, zinc pyrithione or selenium sulfide or tar containing products] within 1 week of screening).
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 |
|---|---|---|
| Terbinafine hydrochloride (HCl)Also: LamisilTerbinafine hydrochloride (HCl) pediatric formulation (minitablets)o.d. administration | Drug | 1 |
| GriseofulvinAlso: Grilfulvin VGriseofulvin pediatric suspension o.d. administration | Drug | 2 |
Primary outcome
Complete cure (negative mycology and clinical cure) rate at Week 10
3 secondary outcomes
Clinical cure rate at Week 10
Mycological cure rate at Week 10
Safety of terbinafine
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 31 May 2017.
- Background: PubMed 18378354Elewski BE, Caceres HW, DeLeon L, El Shimy S, Hunter JA, Korotkiy N, Rachesky IJ, Sanchez-Bal V, Todd G, Wraith L, Cai B, Tavakkol A, Bakshi R, Nyirady J, Friedlander SF. Terbinafine hydrochloride oral granules versus oral griseofulvin suspension in children with tinea capitis: results of two randomized, investigator-blinded, multicenter, international, controlled trials. J Am Acad Dermatol. 2008 Jul;59(1):41-54. doi: 10.1016/j.jaad.2008.02.019. Epub 2008 Apr 18.
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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.
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 3 study testing Terbinafine hydrochloride (HCl) and Griseofulvin in people with Tinea Capitis, run by Novartis Pharmaceuticals at 1 site in United States.
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 2 inclusion and 6 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 31 May 2017. 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 United States. 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. 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 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?
Complete cure (negative mycology and clinical cure) rate at Week 10. 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 NCT00117767, 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 31 May 2017.