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

NCT06436495 | Completed

• 1 other identifier: NB240024-NB-V
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Dandruff

Outcome Measures

Primary Outcomes (2)

• Adherent Scalp Flaking Score

  The score will be assessed by Dermatological Evaluation using the scoring scale where 0 indicates no flakes and 10 indicates heavy flakes

  On Day 1 - pre hair wash, and post hair wash and drying at T30 minutes.

• Scalp Condition using Phototrichogram

  The phototrichogram will be captured using CASLite Nova

  On Day 1 - pre hair wash, and post hair wash and drying at T30 minutes.

Secondary Outcomes (1)

• Non-adherent scalp flakes evaluation

  On Day 1 - pre hair wash, and post hair wash and drying at T30 minutes.

Study Arms (1)

Study Cohort

EXPERIMENTAL

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

Other: Hair Wash Shampoo

Interventions

Hair Wash Shampoo OTHER

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

Also known as: Dove Hair Wash Shampoo

Study Cohort

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• NovoBliss Research Pvt Ltd: lead

Study Sites (1)

NovoBliss Research Pvt Ltd

Gandhinagar, Gujarat, 382421, India

Location

MeSH Terms

Conditions

Dandruff

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Scalp Dermatoses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - Director (Operations)

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 31, 2024
• Study Start: May 22, 2024
• Primary Completion: May 22, 2024
• Study Completion: May 22, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)