Androgenetic AlopeciaNCT06802237
Development and Standardization Methods
An observational study of Androgenetic Alopecia, run by NovoBliss Research Pvt Ltd at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Other
- How many people
- 25 participants
- Where
- 1 siteIndia
- Study dates
- 26 Jul 2024to 26 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects having Alopecia. (Grade I to III)
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Method Development and Standardization Plan for Measuring Hair Growth
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.
Read the 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.
- Conditions
- Androgenetic Alopecia
- Being tested
- Other
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OtherOther
Assess and Evaluate hair growth and scalp health
| Study group | Role | What they receive |
|---|---|---|
| Overall | Not described Receives: Other: Other |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish a standardized methodology that integrates various parameters comprehensively assess and evaluate hair growth and scalp health.
Measured: 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.
Measured: 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.
Measured: 0n Day 1
To establish a standardized methodology for evaluation of hair strength through tensile testing
Evaluated using TESTRONIX Instrument.
Measured: 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.
Measured: 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.
Measured: 0n Day 1
To establish a standardized methodology for assessment of quantitative scalp keratin assessment.
Evaluated using CASLite Nova Instrument
Measured: 0n Day 1
To establish a standardized methodology for assessment of quantitative hair keratin assessment.
Evaluated using Bradford Assay.
Measured: 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
Measured: 0n Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start26 Jul 2024
- Primary completion26 Jul 2024
- Study completion26 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Maheshvari N Patel, Principal investigator, NovoBliss Research Pvt Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802237
- Sponsor's protocol ID
- NB240033-NB-V
- Status last verified
- Feb 2025
- First submitted
- 23 Jan 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Method Development and Standardization Plan for Measuring Hair Growth
- ClinicalTrials.gov ID
- NCT06802237
- Acronym / sponsor ID
- NB240033-NB-V
- Conditions
- Androgenetic Alopecia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- 26 Jul 2024 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overall | – | Other: Other |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects having Alopecia. (Grade I to III)
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OtherAssess and Evaluate hair growth and scalp health | Other | Overall |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Maheshvari N Patel principal investigator
NovoBliss Research Pvt Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Androgenetic Alopecia, run by NovoBliss Research Pvt Ltd at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To establish a standardized methodology that integrates various parameters comprehensively assess and evaluate hair growth and scalp health. (time frame: 0n Day 1). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.