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

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

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.

Study Overview

• Status: Completed
• Conditions: Dandruff
• Intervention / Treatment: Other: Hair Wash Shampoo

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Gandhinagar, Gujarat, India, 382421
      • NovoBliss Research Pvt Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Cohort; The complete study group will be given hair-wash intervention post baseline evaluations.	Other: Hair Wash Shampoo; A standard marketed hair wash shampoo is to be used for the hair wash intervention post baseline evaluations of the scalp.; Other Names: Dove Hair Wash Shampoo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-adherent scalp flakes evaluation	The assessment will be done via 60-second hair combing methods by dermatological assessment using 4 point scoring scale where 0=indicates none and 3 indicates heavy flakes	On Day 1 - pre hair wash, and post hair wash and drying at T30 minutes.

Collaborators and Investigators

• Sponsor: NovoBliss Research Pvt Ltd

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2024
• Primary Completion (Actual): May 22, 2024
• Study Completion (Actual): May 22, 2024

Study Registration Dates

• First Submitted: May 24, 2024
• First Submitted That Met QC Criteria: May 24, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 26, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Scalp Dermatoses; Dandruff
• Other Study ID Numbers: NB240024-NB-V

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No