## Protocol Section
### Identification Module
**NCT ID:** NCT06431542

**Brief Title:** Efficacy of Self vs. Physician Application of Triamcinolone-Econazole in Otomycosis

**Official Title:** Comparison of the Efficacy of Patient Self-Application Versus Physician Application of Triamcinolone Acetonide Econazole Cream in the Treatment of Otomycosis

#### Organization Study ID Info
**ID:** XMZSYYKY2024-047
#### Organization
**Class:** OTHER
**Full Name:** Zhongshan Hospital Xiamen University
### Status Module
#### Completion Date
**Date:** 2025-03

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-18
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Zhongshan Hospital Xiamen University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** to analyze the clinical characteristics, types of Fungal Infections, and comparison of the efficacy of patient self-application versus physician application of triamcinolone acetonide econazole cream in otomycosis treatment.

**Detailed Description:** The study analyzes the clinical characteristics, including symptoms and physical examinations, as well as the types of fungal infections. It compares the efficacy of patient self-application versus physician application of triamcinolone acetonide econazole cream in treating otomycosis two weeks after starting treatment. Furthermore, the study also compares the recurrence rates six months after treatment.

### Conditions Module

**Conditions:**

- Otomycosis

**Keywords:**

- triamcinolone acetonide econazole cream

- otomycosis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 200

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The doctor provided detailed instructions for the patient to self-apply Triamcinolone Acetonide Econazole Cream to the external auditory canal once daily for two weeks.

**Intervention Names:**

- Procedure: patient-applied Triamcinolone Acetonide Econazole Cream

**Label:** patient-applied medication group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** The doctor applied Triamcinolone Acetonide Econazole Cream for patients once every 2 to 3 days, for a total of three applications.

**Intervention Names:**

- Procedure: physician-applied Triamcinolone Acetonide Econazole Cream

**Label:** physician-applied medication group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- physician-applied medication group

**Description:** The doctor applies the Triamcinolone Acetonide Econazole Cream onto a thin cotton swab and gently inserts it deep into the ear canal, evenly spreading the cream around the sides of the ear canal and on the surface of the eardrum.

**Name:** physician-applied Triamcinolone Acetonide Econazole Cream

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- patient-applied medication group

**Description:** The patient applies Triamcinolone Acetonide Econazole Cream in the external auditory canal at home using a cotton swab.

**Name:** patient-applied Triamcinolone Acetonide Econazole Cream

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Treatment efficacy is defined as the proportion of patients who are effective after two weeks of treatment. Effectiveness is defined by the absence of abnormalities in the external auditory canal and the alleviation of symptoms.

**Measure:** treatment efficacy

**Time Frame:** 2 weeks

#### Secondary Outcomes

**Description:** Recurrence rate is assessed six months later during a follow-up examination, where the presence of abnormal secretions in the ear canal and the recurrence of symptoms are noted.

**Measure:** recurrece rate

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 1.The chief complaint was ear discomfort, including tinnitus, a feeling of blockage or fullness, pruritis, otalgia, otorrhea and decreased hearing; 2. Physical examination findings:presence of fungal hyphae or accumulations that appear creamy or cheese-like or resembling abnormal earwax (crusts, films) , skin redness, erosion, swelling, or granulation tissue within the ear canal; 3. Positive results in fungal culture.

Exclusion Criteria:

* The exclusion criteria included otitis media, tympanic membrane perforation, and conditions post-radiotherapy.

**Maximum Age:** 100 Years

**Minimum Age:** 4 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** 578881502@qq.com

**Name:** Chunsheng Ye, MD

**Phone:** +8613400661815

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Xiamen

**Contacts:**

***Contact 1:***

- **Email:** 578881502@qq.com

- **Name:** Chunsheng Ye, MD

- **Phone:** +8613400661815

- **Role:** CONTACT

**Country:** China

**Facility:** Xiamen University Zhongshan Hospital

**State:** Fujian

**Zip:** 361000

#### Overall Officials

**Official 1:**

**Affiliation:** Xiamen University Zhongshan Hospital

**Name:** Chunsheng Chunsheng

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009181

- Term: Mycoses

- ID: D000001423

- Term: Bacterial Infections and Mycoses

- ID: D000007239

- Term: Infections

- ID: D000004427

- Term: Ear Diseases

- ID: D000010038

- Term: Otorhinolaryngologic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC09

- Name: Ear, Nose, and Throat Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M29414

- Name: Otomycosis

- Relevance: HIGH

- As Found: Otomycosis

- ID: M12136

- Name: Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4722

- Name: Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M4721

- Name: Bacterial Infections and Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: M7601

- Name: Ear Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12961

- Name: Otorhinolaryngologic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000059249

- Term: Otomycosis

### Intervention Browse Module - Ancestors

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000005938

- Term: Glucocorticoids

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000007166

- Term: Immunosuppressive Agents

- ID: D000007155

- Term: Immunologic Factors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000935

- Term: Antifungal Agents

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000058888

- Term: 14-alpha Demethylase Inhibitors

- ID: D000065607

- Term: Cytochrome P-450 Enzyme Inhibitors

- ID: D000065088

- Term: Steroid Synthesis Inhibitors

- ID: D000006727

- Term: Hormone Antagonists

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

### Intervention Browse Module - Browse Leaves

- ID: M7635

- Name: Econazole

- Relevance: HIGH

- As Found: Czech

- ID: M16974

- Name: Triamcinolone

- Relevance: HIGH

- As Found: Subcutaneous injection

- ID: M16975

- Name: Triamcinolone Acetonide

- Relevance: HIGH

- As Found: Combination Therapy

- ID: M237966

- Name: Triamcinolone hexacetonide

- Relevance: HIGH

- As Found: Combination Therapy

- ID: M209573

- Name: Triamcinolone diacetate

- Relevance: HIGH

- As Found: Combination Therapy

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M9047

- Name: Glucocorticoids

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M10212

- Name: Immunosuppressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M6252

- Name: Clotrimazole

- Relevance: LOW

- As Found: Unknown

- ID: M11796

- Name: Miconazole

- Relevance: LOW

- As Found: Unknown

- ID: M4254

- Name: Antifungal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M30537

- Name: Cytochrome P-450 Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000004464

- Term: Econazole

- ID: D000014221

- Term: Triamcinolone

- ID: D000014222

- Term: Triamcinolone Acetonide

- ID: C000005900

- Term: Triamcinolone hexacetonide

- ID: C000030262

- Term: Triamcinolone diacetate

### Misc Info Module

- Version Holder: 2024-05-31
