Development and Standardization Methods

NCT ID: NCT06802237

Last Updated: 2025-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-26

Study Completion Date

2024-07-26

Brief Summary

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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

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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.

Conditions

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Androgenetic Alopecia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Overall

Other

Intervention Type OTHER

Assess and Evaluate hair growth and scalp health

Interventions

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Other

Assess and Evaluate hair growth and scalp health

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NovoBliss Research Pvt Ltd

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. Maheshvari N Patel

Role: PRINCIPAL_INVESTIGATOR

NovoBliss Research Pvt Ltd

Locations

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NovoBliss Research Pvt Ltd

Ahmedabad, Gujarat, India

Site Status

Countries

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India

Other Identifiers

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NB240033-NB-V

Identifier Type: -

Identifier Source: org_study_id

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