Development and Standardization Methods

NCT06802237 | Completed

• 1 other identifier: NB240033-NB-V
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (1)

Overall

Other: Other

Interventions

Other OTHER

Assess and Evaluate hair growth and scalp health

Overall

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Subjects having Alopecia. (Grade I to III)

You may qualify if:

• 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.
• Patient having androgenic alopecia condition with grade of 1 to 3 (Dermatological assessment)

You may not qualify if:

• Recent hair transplantation or other surgical interventions on the scalp within the past year.
• Pregnant or breastfeeding women will be excluded due to potential hormonal influences on hair growth.
• History of cancer treatment involving chemotherapy or radiotherapy to the scalp.
• Presence of significant dermatological conditions affecting the scalp other than androgenetic alopecia (e.g., psoriasis, severe seborrheic dermatitis).
• History of major systemic diseases (e.g., uncontrolled diabetes, severe cardiovascular diseases, autoimmune disorders).

Sponsors & Collaborators

• NovoBliss Research Pvt Ltd: lead

Study Sites (1)

NovoBliss Research Pvt Ltd

Ahmedabad, Gujarat, 382481, India

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr. Maheshvari N Patel

  NovoBliss Research Pvt Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 31, 2025
• Study Start: July 26, 2024
• Primary Completion: July 26, 2024
• Study Completion: July 26, 2024
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)