Clinical trial NCT06802237: Development and Standardization Methods
Official title: Clinical Method Development and Standardization Plan for Measuring Hair Growth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Androgenetic Alopecia
Lead sponsor: NovoBliss Research Pvt Ltd
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects having Alopecia. (Grade I to III)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To establish a standardized methodology that integrates various parameters comprehensively assess and evaluate hair growth and scalp health.
timeFrame: 0n Day 1
measure: To establish a standardized methodology for measurement of hair regrowth from AGA-affected area (bald scalp) and tattoo area.
timeFrame: 0n Day 1
measure: To establish a standardized methodology for evaluating number of new hairs from the AGA-affected area (bald scalp) and tattoo area.
timeFrame: 0n Day 1
measure: To establish a standardized methodology for evaluation of hair strength through tensile testing
timeFrame: 0n Day 1
measure: To establish a standardized methodology for assessment of hair length
timeFrame: 0n Day 1
measure: To establish a standardized methodology for assessment of Global picture of head crown
timeFrame: 0n Day 1
measure: To establish a standardized methodology for assessment of quantitative scalp keratin assessment.
timeFrame: 0n Day 1
measure: To establish a standardized methodology for assessment of quantitative hair keratin assessment.
timeFrame: 0n Day 1
measure: To establish a standardized methodology for quantitative scoring of baldness using the Norwood-Hamilton and Ludwig scales and its inter-observer variability.
timeFrame: 0n Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: NovoBliss Research Pvt Ltd
state: Gujarat
Study officials:
affiliation: NovoBliss Research Pvt Ltd
name: Dr. Maheshvari N Patel
role: PRINCIPAL_INVESTIGATOR
References: