Development and Standardization Methods

Clinical Method Development and Standardization Plan for Measuring Hair Growth

The objective of this study is to establish a standardized methodology that integrates various parameters to comprehensively assess and evaluate hair growth and scalp health.

Study Overview

• Status: Completed
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Other: Other

Detailed Description

A total of 25 participants, consisting of 13 males and 12 females who have complaints of androgenetic alopecia (AGA) will be enrolled.

This research seeks to develop and implement a robust and standardized approach that incorporates a diverse range of parameters. These parameters include:

• Measurement of hair regrowth from AGA-affected area.
• Number of new hairs from the AGA-affected area and tattoo area.
• Evaluation of hair strength through tensile testing.
• Assessment of hair length
• Global picture of head crown
• Quantitative analysis of scalp keratin levels.
• Visual documentation and quantitative scoring of baldness using the Norwood-Hamilton and Ludwig scales and its inter-variability.

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 382481
      • NovoBliss Research Pvt Ltd

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

Subjects having Alopecia. (Grade I to III)

Description

Inclusion Criteria:

1. Age between 18 and 55 years (both inclusive).
2. Good general health as determined from recent medical history.
3. No previous history of adverse skin conditions, and not under any medication likely to interfere with the results.
4. Patient having androgenic alopecia condition with grade of 1 to 3 (Dermatological assessment)

Exclusion Criteria:

1. Recent hair transplantation or other surgical interventions on the scalp within the past year.
2. Pregnant or breastfeeding women will be excluded due to potential hormonal influences on hair growth.
3. History of cancer treatment involving chemotherapy or radiotherapy to the scalp.
4. Presence of significant dermatological conditions affecting the scalp other than androgenetic alopecia (e.g., psoriasis, severe seborrheic dermatitis).
5. History of major systemic diseases (e.g., uncontrolled diabetes, severe cardiovascular diseases, autoimmune disorders).
6. Any other condition which could warrant exclusion from the study, as per the dermatologist/investigator's discretion.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Overall	Other: Other; Assess and Evaluate hair growth and scalp health

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To establish a standardized methodology that integrates various parameters comprehensively assess and evaluate hair growth and scalp health.		0n Day 1
To establish a standardized methodology for measurement of hair regrowth from AGA-affected area (bald scalp) and tattoo area.	Evaluated using the standardized area 30 cm from nose tip followed by the CASLite Nova.	0n Day 1
To establish a standardized methodology for evaluating number of new hairs from the AGA-affected area (bald scalp) and tattoo area.	Evaluated using the standardized area 30 cm from nose tip followed by the CASLite Nova.	0n Day 1
To establish a standardized methodology for evaluation of hair strength through tensile testing	Evaluated using TESTRONIX Instrument.	0n Day 1
To establish a standardized methodology for assessment of hair length	Evaluated using the standardized area 15 cm away from the tip of the nose towards scalp vertex.	0n Day 1
To establish a standardized methodology for assessment of Global picture of head crown	Evaluated digital photographs of the alopecia at 0° Angle, 45° Angle, 90° Angle.	0n Day 1
To establish a standardized methodology for assessment of quantitative scalp keratin assessment.	Evaluated using CASLite Nova Instrument	0n Day 1
To establish a standardized methodology for assessment of quantitative hair keratin assessment.	Evaluated using Bradford Assay.	0n Day 1
To establish a standardized methodology for quantitative scoring of baldness using the Norwood-Hamilton and Ludwig scales and its inter-observer variability.	Evaluated using certified Dermatologist where type I = Minimal recession of the hairline and type Va indicates Most advanced degree of alopecia	0n Day 1

Collaborators and Investigators

• Sponsor: NovoBliss Research Pvt Ltd
• Investigators: Principal Investigator: Dr. Maheshvari N Patel, NovoBliss Research Pvt Ltd

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2024
• Primary Completion (Actual): July 26, 2024
• Study Completion (Actual): July 26, 2024

Study Registration Dates

• First Submitted: January 23, 2025
• First Submitted That Met QC Criteria: January 29, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Alopecia
• Other Study ID Numbers: NB240033-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