NovoBliss Research Pvt Ltd
Ahmedabad, Gujarat, 382481, India
Completed
NCT Number: NCT06802237
Development and Standardization Methods
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.
Completed
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Conditions
Age range
18 year–55 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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)
Exclusion criteria
- 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).
- Any other condition which could warrant exclusion from the study, as per the dermatologist/investigator's discretion.
Treatment and study plan
other
OtherAssess and Evaluate hair growth and scalp health
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.
Time frame: 0n Day 1
Evaluated 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.
Time frame: 0n Day 1
Evaluated 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 testing
Time frame: 0n Day 1
Evaluated using TESTRONIX Instrument.
-
To establish a standardized methodology for assessment of hair length
Time frame: 0n Day 1
Evaluated 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 crown
Time frame: 0n Day 1
Evaluated digital photographs of the alopecia at 0° Angle, 45° Angle, 90° Angle.
-
To establish a standardized methodology for assessment of quantitative scalp keratin assessment.
Time frame: 0n Day 1
Evaluated using CASLite Nova Instrument
-
To establish a standardized methodology for assessment of quantitative hair keratin assessment.
Time frame: 0n Day 1
Evaluated 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.
Time frame: 0n Day 1
Evaluated using certified Dermatologist where type I = Minimal recession of the hairline and type Va indicates Most advanced degree of alopecia
Sponsors and collaborators
Lead sponsor
NovoBliss Research Pvt Ltd
Other
Registry information
Official study title
Clinical Method Development and Standardization Plan for Measuring Hair Growth
Important dates
- Study start
- 2024
- Primary completion
- 2024
- Study completion
- 2024
- First posted
- Jan 31, 2025
- Registry last updated
- Mar 3, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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