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Development and Standardization Methods

Clinical Method Development and Standardization Plan for Measuring Hair Growth

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06802237
Enrollment
25
Registered
2025-01-31
Start date
2024-07-26
Completion date
2024-07-26
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Androgenetic Alopecia

Brief summary

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.

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.

Interventions

OTHEROther

Assess and Evaluate hair growth and scalp health

Sponsors

NovoBliss Research Pvt Ltd
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
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.0n Day 1Evaluated using the standardized area 30 cm from nose tip followed by the CASLite Nova.
To establish a standardized methodology for evaluating number of new hairs from the AGA-affected area (bald scalp) and tattoo area.0n Day 1Evaluated using the standardized area 30 cm from nose tip followed by the CASLite Nova.
To establish a standardized methodology for evaluation of hair strength through tensile testing0n Day 1Evaluated using TESTRONIX Instrument.
To establish a standardized methodology for assessment of hair length0n Day 1Evaluated using the standardized area 15 cm away from the tip of the nose towards scalp vertex.
To establish a standardized methodology for assessment of Global picture of head crown0n Day 1Evaluated digital photographs of the alopecia at 0° Angle, 45° Angle, 90° Angle.
To establish a standardized methodology for assessment of quantitative scalp keratin assessment.0n Day 1Evaluated using CASLite Nova Instrument
To establish a standardized methodology for assessment of quantitative hair keratin assessment.0n Day 1Evaluated using Bradford Assay.
To establish a standardized methodology for quantitative scoring of baldness using the Norwood-Hamilton and Ludwig scales and its inter-observer variability.0n Day 1Evaluated using certified Dermatologist where type I = Minimal recession of the hairline and type Va indicates Most advanced degree of alopecia

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026