DandruffNCT06436495
Methodology Validation: Correlating Adherent Scalp Flaking Score (ASFS) With Phototrichogram for Scalp Dandruff Evaluation in Adult Subjects
A study of Dandruff, run by NovoBliss Research Pvt Ltd at 1 site in India.
Trial summary
This study aims to validate methods for assessing scalp hair dandruff by comparing three evaluation techniques: the Adherent Scalp Flaking Score (ASFS), Phototrichogram, and 60-second hair combing. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dandruff
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteIndia
- Study dates
- 22 May 2024to 22 May 2024
- Phase
- Interventional
- 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
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.
Who cannot join
- Non-willing subjects and subjects with a history of allergies or specific allergic reactions upon using dermatological/cosmetic products will not be included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Methodologies: Correlating Adherent Scalp Flaking Score (ASFS) With Phototrichogram for Comprehensive Evaluation of Scalp Dandruff in Adults
This study aims to validate methods for assessing scalp hair dandruff by comparing three evaluation techniques: the Adherent Scalp Flaking Score (ASFS), Phototrichogram, and 60-second hair combing.
These assessments will be conducted before and after hair wash interventions on adult human subjects to evaluate adherent and non-adherent scalp flakes. By comparing the results of these evaluations, the study aims to determine the consistency and reliability of each method in assessing the presence and severity of dandruff. Establishing correlation between these assessment techniques is essential for validating their usefulness in evaluating the effectiveness of hair care products and treatments in reducing scalp dandruff. This research aims to improve the accuracy and reliability of dandruff evaluation methods, benefiting both dermatological research and clinical practice in managing this prevalent condition.
- Conditions
- Dandruff
- Being tested
- Hair Wash Shampoo
- Medical subject headings
- Dandruff
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hair Wash ShampooOther
Also called Dove Hair Wash Shampoo
A standard marketed hair wash shampoo is to be used for the hair wash intervention post baseline evaluations of the scalp.
| Study group | Role | What they receive |
|---|---|---|
| Study Cohort | Experimental | The complete study group will be given hair-wash intervention post baseline evaluations. Receives: Other: Hair Wash Shampoo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherent Scalp Flaking Score
The score will be assessed by Dermatological Evaluation using the scoring scale where 0 indicates no flakes and 10 indicates heavy flakes
Measured: On Day 1 - pre hair wash, and post hair wash and drying at T30 minutes.
Scalp Condition using Phototrichogram
The phototrichogram will be captured using CASLite Nova
Measured: On Day 1 - pre hair wash, and post hair wash and drying at T30 minutes.
Secondary outcomes (1)
Non-adherent scalp flakes evaluation
The assessment will be done via 60-second hair combing methods by dermatological assessment using 4 point scoring scale where 0=indicates none and 3 indicates heavy flakes
Measured: On Day 1 - pre hair wash, and post hair wash and drying at T30 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start22 May 2024
- Primary completion22 May 2024
- Study completion22 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DandruffStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maheshvari Patel, NovoBliss Research Pvt Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436495
- Sponsor's protocol ID
- NB240024-NB-V
- Status last verified
- Jun 2024
- First submitted
- 24 May 2024
- Last updated
- 27 Jun 2024
- 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 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Methodologies: Correlating Adherent Scalp Flaking Score (ASFS) With Phototrichogram for Comprehensive Evaluation of Scalp Dandruff in Adults
- ClinicalTrials.gov ID
- NCT06436495
- Acronym / sponsor ID
- NB240024-NB-V
- Conditions
- Dandruff
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Study start
- 22 May 2024 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 31 May 2024 (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.
This study aims to validate methods for assessing scalp hair dandruff by comparing three evaluation techniques: the Adherent Scalp Flaking Score (ASFS), Phototrichogram, and 60-second hair combing.
These assessments will be conducted before and after hair wash interventions on adult human subjects to evaluate adherent and non-adherent scalp flakes. By comparing the results of these evaluations, the study aims to determine the consistency and reliability of each method in assessing the presence and severity of dandruff. Establishing correlation between these assessment techniques is essential for validating their usefulness in evaluating the effectiveness of hair care products and treatments in reducing scalp dandruff. This research aims to improve the accuracy and reliability of dandruff evaluation methods, benefiting both dermatological research and clinical practice in managing this prevalent condition.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | Experimental | Other: Hair Wash ShampooThe complete study group will be given hair-wash intervention post baseline evaluations. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 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.
Key exclusion criteria (1 listed)
- Non-willing subjects and subjects with a history of allergies or specific allergic reactions upon using dermatological/cosmetic products will not be included.
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 |
|---|---|---|
| Hair Wash ShampooAlso: Dove Hair Wash ShampooA standard marketed hair wash shampoo is to be used for the hair wash intervention post baseline evaluations of the scalp. | Other | Study Cohort |
Primary outcome
Adherent Scalp Flaking Score
Time frame: On Day 1 - pre hair wash, and post hair wash and drying at T30 minutes.
The score will be assessed by Dermatological Evaluation using the scoring scale where 0 indicates no flakes and 10 indicates heavy flakes
Scalp Condition using Phototrichogram
Time frame: On Day 1 - pre hair wash, and post hair wash and drying at T30 minutes.
The phototrichogram will be captured using CASLite Nova
1 secondary outcome
Non-adherent scalp flakes evaluation
Time frame: On Day 1 - pre hair wash, and post hair wash and drying at T30 minutes.
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 27 Jun 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Dandruff, 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 3 inclusion and 1 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 27 Jun 2024. 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?
Adherent Scalp Flaking Score (time frame: On Day 1 - pre hair wash, and post hair wash and drying at T30 minutes.). The study lists 2 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 27 Jun 2024; AzTrials last refreshed its copy on 1 Nov 2026.