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Completed

NCT Number: NCT06436495

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

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.

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Key information

Conditions

Dandruff Dermatitis Scalp Dermatoses Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NovoBliss Research Pvt Ltd

Gandhinagar, Gujarat, 382421, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Dove Hair Wash Shampoo

Primary outcomes

  1. Adherent Scalp Flaking Score

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

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

  2. Scalp Condition using Phototrichogram

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

    The phototrichogram will be captured using CASLite Nova

Secondary outcomes

  1. Non-adherent scalp flakes evaluation

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

    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

Sponsors and collaborators

Lead sponsor

NovoBliss Research Pvt Ltd

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 31, 2024
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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