Development and Standardization Methods

NovoBliss Research Pvt Ltd25 enrolled

Overview

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.

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

Conditions

Androgenetic Alopecia

Interventions

OtherOTHER

Assess and Evaluate hair growth and scalp health

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

NovoBliss Research Pvt Ltd

Ahmedabad, Gujarat, India

Outcomes

Primary Outcomes

To establish a standardized methodology that integrates various parameters comprehensively assess and evaluate hair growth and scalp health.

Time frame: 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.

Time frame: 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.

Time frame: 0n Day 1

To establish a standardized methodology for evaluation of hair strength through tensile testing

Evaluated using TESTRONIX Instrument.

Time frame: 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.

Time frame: 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.

Time frame: 0n Day 1

To establish a standardized methodology for assessment of quantitative scalp keratin assessment.

Evaluated using CASLite Nova Instrument

Time frame: 0n Day 1

To establish a standardized methodology for assessment of quantitative hair keratin assessment.

Data from ClinicalTrials.gov

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