## Protocol Section
### Identification Module
**NCT ID:** NCT06436495

**Brief Title:** Methodology Validation: Correlating Adherent Scalp Flaking Score (ASFS) With Phototrichogram for Scalp Dandruff Evaluation in Adult Subjects

**Official Title:** Validation of Methodologies: Correlating Adherent Scalp Flaking Score (ASFS) With Phototrichogram for Comprehensive Evaluation of Scalp Dandruff in Adults

#### Organization Study ID Info
**ID:** NB240024-NB-V
#### Organization
**Class:** OTHER
**Full Name:** NovoBliss Research Pvt Ltd
### Status Module
#### Completion Date
**Date:** 2024-05-22

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-24

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-05-22

**Type:** ACTUAL

#### Start Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** NovoBliss Research Pvt Ltd

#### Responsible Party

**Investigator Affiliation:** NovoBliss Research Pvt Ltd

**Investigator Full Name:** Maheshvari Patel

**Investigator Title:** Principal Investigator - Director (Operations)

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study aims to validate methods for assessing scalp hair dandruff by comparing three evaluation techniques: the Adherent Scalp Flaking Score (ASFS), Phototrichogram, and 60-second hair combing.

These assessments will be conducted before and after hair wash interventions on adult human subjects to evaluate adherent and non-adherent scalp flakes. By comparing the results of these evaluations, the study aims to determine the consistency and reliability of each method in assessing the presence and severity of dandruff. Establishing correlation between these assessment techniques is essential for validating their usefulness in evaluating the effectiveness of hair care products and treatments in reducing scalp dandruff. This research aims to improve the accuracy and reliability of dandruff evaluation methods, benefiting both dermatological research and clinical practice in managing this prevalent condition.

### Conditions Module

**Conditions:**

- Dandruff

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 12

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The complete study group will be given hair-wash intervention post baseline evaluations.

**Intervention Names:**

- Other: Hair Wash Shampoo

**Label:** Study Cohort

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Study Cohort

**Description:** A standard marketed hair wash shampoo is to be used for the hair wash intervention post baseline evaluations of the scalp.

**Name:** Hair Wash Shampoo

**Other Names:**

- Dove Hair Wash Shampoo

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The score will be assessed by Dermatological Evaluation

**Measure:** Adherent Scalp Flaking Score

**Time Frame:** On Day 1 - pre hair wash, and post hair wash and drying at T30 minutes.

**Description:** The phototrichogram will be captured using CASLite Nova

**Measure:** Scalp Condition using Phototrichogram

**Time Frame:** On Day 1 - pre hair wash, and post hair wash and drying at T30 minutes.

#### Secondary Outcomes

**Description:** The assessment will be done via 60-second hair combing methods by dermatological assessment

**Measure:** Non-adherent scalp flakes evaluation

**Time Frame:** On Day 1 - pre hair wash, and post hair wash and drying at T30 minutes.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age between 18 and 55 years (both inclusive).
* Good general health as determined from recent medical history.
* No previous history of adverse skin conditions, and not under any medication likely to interfere with the results.

Exclusion Criteria:

* Non-willing subjects and subjects with a history of allergies or specific allergic reactions upon using dermatological/cosmetic products will not be included.

**Healthy Volunteers:** True

**Maximum Age:** 55 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Gandhinagar

**Country:** India

**Facility:** NovoBliss Research Pvt Ltd

**State:** Gujarat

**Zip:** 382421

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003872

- Term: Dermatitis

- ID: D000012871

- Term: Skin Diseases

- ID: D000012536

- Term: Scalp Dermatoses

### Condition Browse Module - Browse Branches

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M30157

- Name: Dandruff

- Relevance: HIGH

- As Found: Dandruff

- ID: M7067

- Name: Dermatitis

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15354

- Name: Scalp Dermatoses

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000063807

- Term: Dandruff

### Misc Info Module

- Version Holder: 2024-05-31
