Safety and Efficacy of NAFT900 in Children With Tinea Capitis

Tinea Capitis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02658292
• Other study ID #: M902001001
• Status: Withdrawn
• Phase: Phase 2
• First received: January 12, 2016
• Last updated: September 8, 2016

Study information

• Verified date: September 2016
• Source: Merz Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

1. Subjects with clinical diagnosis of tinea capitis with =15% involvement of the scalp.

2. Subjects with positive KOH microscopy and culture [for dermatophytes].

3. Male or female subjects =6 years and <13 years of age on the date of the Baseline Visit.

Exclusion Criteria:

1. Subject with acute inflammatory fungal infection of the scalp (kerion)

2. 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).

3. Subjects who received immunosuppressant therapy, cytostatic therapy or radiation therapy within 4 weeks prior to the baseline.

4. Subjects who received systemic corticosteroids and/or systemic antibiotics within 4 weeks prior to study entry (or during study).

5. Subjects who have used systemic antifungal treatment within 4 weeks prior to the baseline.

6. 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.

7. 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinea
• Tinea Capitis

Intervention

Drug:
• Naftifine hydrochloride foam, 3%
Apply NAFT900 foam twice daily to the affected area(s) plus half-inch around each affected area for 4 weeks
• Vehicle
Apply vehicle foam twice daily to the affected area(s) plus half-inch around each affected area for 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merz Pharmaceuticals, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	8 weeks	No
Secondary	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	8 weeks	No
Secondary	Compare the proportion of subjects with mycological cure	Mycological cure is defined as complete cure defined as negative KOH microscopy and negative dermatophyte culture	8 weeks	No