Hair ThinningNCT05800496
A Clinical Study to Assess the Safety and Effectiveness of Plant Based Biotin in Healthy Human Subjects With Thin, Dry, and Brittle Hair
A study testing SesZen-Bio™ in people with Hair Thinning and Hair Brittle, run by NovoBliss Research Pvt Ltd at 1 site in India.
Trial summary
This is a randomized, placebo-controlled, double-blind, two-arm, single-centre, proof-of-concept, clinical study to evaluate the safety and efficacy of Plant based Biotin in Healthy Human Subjects with thin, dry, and brittle hair. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hair Thinning, Hair Brittle, Dry Hair
- What is being tested?
- SesZen-Bio™
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteIndia
- Study dates
- 31 Oct 2022to 10 Jan 2023
- 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 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 30 to 55 years (both inclusive) at the time of consent.
- Sex: Healthy males and non-pregnant/non-lactating females.
- Females of childbearing potential must have a self-reported negative pregnancy test.
- Subjects are generally in good health.
- Subject with self-proclaimed nonpathological thin, dry and brittle hair.
- Subject with normal Fitzpatrick skin type III to VI (Human skin colour determination scale).
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- Subject has a score of at least "mild skin aging" based on PGA at screening visit.
- Subject with Glogau Skin Age II or III as assessed by the Dermatologist/ Dermatologist Trained Evaluator.
- Subject is willing to forgo cosmetic procedures 3 months prior to and for the duration of the study.
- Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
- Subject is able to follow their normal skin care routines and to refrain from introducing any new skin care products during the study.
- Subject is able to forgo changes in baseline medications and nutritional supplements during the study period.
- If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post- menopausal for at least 1 year or have had a tubal ligation.
- If currently using hormonal contraception, has been using this form of contraception for at least 6 months and agrees to continue using the same contraception for the duration of the study.
- Subjects are willing not to introduce any new soaps, cleansers, laundry detergents, lotions, creams, shampoos etc. for the duration of the study.
- Subjects are willing to give written informed consent and are willing to follow the study procedure.
- Subjects who have used other marketed products for hair thinning in the past.
- Subjects who commit not to use medicated/ prescription shampoos/hair care products (containing Minoxidil / Anti-thinning agents) or any other hair growth, treatment for thin hair, or hair products other than the test product for the entire duration of the study.
- Willing to use test product throughout the study period
Who cannot join
- Subjects with a history of hair thinning/hair fall due to any clinically significant problems/s like anaemia, thyroid problems, etc.
- Subject has a history of allergy or sensitivity to the test treatment ingredients like sesbania agati and others etc.
- Subject has a history of any dermatological condition of the scalp other than hair loss and/or dandruff or active dermatological condition that might interfere with the clinical assessments (e.g. tattoos, eczema, psoriasis, acne, etc.).
- Subject has used any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks prior to the start or anticipates having to use at any point during the study.
- Subject has applied any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study.
- Subject is not willing to avoid unprotected sun or other UV radiation exposure during the study period.
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- Subject is currently pregnant/breastfeeding.
- Subject has a history of prior use of hair growth treatment within 3 months.
- Subject has a history of any prior hair growth procedures (e.g., hair transplant or laser).
- Subject has a history of alcohol or drug addiction.
- Subjects who have plans of shaving scalp hair during the study.
- Subject has a past or present condition of irritated or visibly inflamed scalp or severe scalp disease.
- Subject who is currently participating in or planning on starting weight loss program that may result in a significant change in overall body weight.
- Any other condition which could warrant exclusion from the study, as per the dermatologist's/investigator's discretion.
- Pregnant or breastfeeding or planning to become pregnant during the study period.
- History of chronic illness which may influence the cutaneous state.
- Subjects participating in other similar cosmetics, devices or therapeutic trials or hair/scalp/skin care products within the last four weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Proof-of-Concept, Placebo-Controlled, Safety, and Efficacy Study of Plant Based Biotin in Healthy Adult Human Subjects With Thin, Dry, and Brittle Hair
This is a randomized, placebo-controlled, double-blind, two-arm, single-centre, proof-of-concept, clinical study to evaluate the safety and efficacy of Plant based Biotin in Healthy Human Subjects with thin, dry, and brittle hair.
a sufficient number (maximum of 54 (27/arm)) of female/male adult subjects were recruited/enrolled to ensure a total of 50 subjects (25 subjects/arm) completed the study.
Read the detailed description
This is a randomised, placebo-controlled, double-blind, two-arm, single-centre, proof-of-concept, clinical study to evaluate the safety and efficacy of Plant based Biotin in Healthy Human Subjects with thin, dry and brittle hair.
a sufficient number (maximum of 54 (27/arm)) of female/male adult subjects were recruited/enrolled to ensure a total of 50 subjects (25 subjects/arm) completed the study.
total of 51 subjects was completed the study. The potential subjects were screened as per the inclusion \& exclusion criteria only after obtaining written informed consent from the subjects. The adult female/male subjects were instructed to visit the facility as per the below visits.
- Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluations
- Visit 02 (Day 28): Treatment Period, Evaluations
- Visit 03 (Day 56): Evaluations, End of Study Visit Subjects were pre-screened by the screening department of NovoBliss Research. Subjects were called on the telephone by the recruiting department prior to the enrolment visit. Subjects were told during screening (prior to enrolment) not to wear any facial make-up or use any hair product on the study visit day.
Assessment of efficacy parameters before test treatment usage was done on day 1, and after test treatment usage was done on day 28, and day 56 as listed below.
- General Appearance of Hair i.e., hair volume, hair reflection, hair plasticity, hair density, hair smoothness, hair oiliness, hair shininess.
- General Appearance of Scalp i.e., Scalp itchiness, redness, scaling.
- CASLite Nova: Hair Density, Thickness, scalp condition
- Visioscan (C+K Instrument): Crow's feet area wrinkles, fine lines, skin texture - roughness,
- Skin Colorimeter CL 400: Right cheek skin colour evenness L*, a* b* and RGB, ITA Angle
- DermaLab®Combo - skin elasticity (Right cheek)
- MoitureMeterEPiD: Skin Hydration (Right cheek)
- Vapometer: Skin Barrier function - Transepidermal water loss (Right cheek)
- Physician Global Assessment for improvement in brittle nails - Day 01 and Day 56
- Serum Ferratin Biomarker test (Day 1 as baseline and Day 56)
- Digital Photographs: Facial photographs Before test treatment usage and after test treatment usage.
- Subjective Product Perception Assessment regarding the test product's effect on hair and skin firmness, appearance, nails etc
- Conditions
- Hair Thinning, Hair Brittle, Dry Hair
- Being tested
- SesZen-Bio™, Placebo
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SesZen-Bio™Dietary supplement
mode of usage: 1 capsule in the morning and 1 capsule at night. administration: Oral Administration
PlaceboOther
Mode of Usage: 1 capsule in the morning and 1 capsule at night. Route of Administration: Oral Administration
| Study group | Role | What they receive |
|---|---|---|
| SesZen-Bio™ | Experimental | SesZen-Bio™ is specially formulated for healthy hairs and healthy skin. Fortified with Sesbania Agati for 2X Hair Follicle Stimulation \& Hair Fall Control, to Promote Shiny Hair, biotin that Supports Hair Growth. Receives: Dietary Supplement: SesZen-Bio™ |
| Placebo (Tapioca based starch Capsules) | Placebo comparator | tapioca starch, is a starchy white flour that has a slight sweet flavor to it and is prepared by extrusion and coating process. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hair Density
To evaluate the effectiveness of test treatment in terms of change in hair density between the treatment and placebo group by using CasaLiteNova (Instrumental Reading)
Measured: Day 01,Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
Change in Hair Thickness
To evaluate the effectiveness of test treatment in terms of change in hair thickness between the treatment and placebo group by using CasaLiteNova (Instrumental Reading)
Measured: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
Change in Scalp Condition
To evaluate the effectiveness of test treatment in terms of change in scalp condition between the treatment and placebo group by using CasaLiteNova (Instrumental Reading)
Measured: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
Change in Facial Wrinkle
To evaluate the effectiveness of test treatment in terms of reducing facial wrinkle between the treatment and placebo group by using VisioScan (Instrumental Readings)
Measured: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
Change in Fine Lines
To evaluate the effectiveness of test treatment in terms of reducing fine lines between the treatment and placebo group by using VisioScan (Instrumental Readings)
Measured: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
Secondary outcomes (10)
Change in Physician Global Assessment (PGA) scoring
To assess the effectiveness of test treatment in terms of change in Physician Global Assessment (PGA) between the treatment and placebo group by using Griffiths Scale 0 point= No appearance, 7-9point= Severe
Measured: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
Change in Glogau Skin Age
To assess the effectiveness of test treatment in terms of change in Glogau Skin Age between the treatment and placebo group by using Glogau Skin Age Classification
Measured: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
Change in Skin Colour
To assess the effectiveness of test treatment in terms of change in skin colour between the treatment and placebo group i.e.L* a* b* and ITA (Individual Topology Angle) using Skin-Colorimeter CL 400 (Instrumental Readings)
Measured: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
Change in Skin Elasticity
To assess the effectiveness of test treatment in terms of change in skin elasticity between the treatment and placebo group by using DermaLab Combo (Instrumental Reading)
Measured: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
Change in Skin Hydration
To assess the effectiveness of test treatment in terms of change in skin hydration between the treatment and placebo group by using MoistureMeterEpiD (Instrumental Reading) the result indicated in %
Measured: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
Change in Skin barrier Function
To assess the effectiveness of test treatment in terms of change in Skin Barrier Function between the treatment and placebo group by using Vapometer (Instrumental Reading) the result indicated in %
Measured: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
Change in Serum Ferritin
To assess the effectiveness of test treatment in terms of change in serum ferritin between the treatment and placebo group
Measured: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
Change in brittle nails
To assess the effectiveness of test treatment in terms of change in brittle nails between the treatment and placebo group by using Physician Global Assessment (PGA) 0=None, 5= Severe
Measured: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
Noticeable Improvement in Facial Photograph
To assess the effectiveness of test treatment in terms of noticeable improvement in Facial Wrinkle between the treatment and placebo group by using Digital Camera (Visual Change)
Measured: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
Subjective Perception Questionnaires
To assess the effectiveness of test treatment in terms of Subjective perception on color, fragrance, taste, skin hydration, skin tone, firmness, appearance, hair and nails strongness and shine between the treatment and placebo group by using 9 point Hedonic scale
Measured: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start31 Oct 2022
- Primary completion13 Dec 2022
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair ThinningStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Proof-of-Concept, Placebo-Controlled, Safety, and Efficacy
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- ZYWIE VENTURES PRIVATE LIMITED
- Responsible party
- Principal investigator, Dr Nayan Patel, NovoBliss Research Pvt Ltd
- Investigators
- Dr. Nayan K Patel, MBBS, Principal investigator, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800496
- Sponsor's protocol ID
- NB220024-FC
- Status last verified
- Mar 2023
- First submitted
- 25 Feb 2023
- Last updated
- 5 Apr 2023
- 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 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-Concept, Placebo-Controlled, Safety, and Efficacy Study of Plant Based Biotin in Healthy Adult Human Subjects With Thin, Dry, and Brittle Hair
- ClinicalTrials.gov ID
- NCT05800496
- Acronym / sponsor ID
- NB220024-FC
- Conditions
- Hair Thinning, Hair Brittle, Dry Hair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Collaborators
- ZYWIE VENTURES PRIVATE LIMITED
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 5 Apr 2023 (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 is a randomized, placebo-controlled, double-blind, two-arm, single-centre, proof-of-concept, clinical study to evaluate the safety and efficacy of Plant based Biotin in Healthy Human Subjects with thin, dry, and brittle hair.
a sufficient number (maximum of 54 (27/arm)) of female/male adult subjects were recruited/enrolled to ensure a total of 50 subjects (25 subjects/arm) completed the study.
Detailed description
This is a randomised, placebo-controlled, double-blind, two-arm, single-centre, proof-of-concept, clinical study to evaluate the safety and efficacy of Plant based Biotin in Healthy Human Subjects with thin, dry and brittle hair.
a sufficient number (maximum of 54 (27/arm)) of female/male adult subjects were recruited/enrolled to ensure a total of 50 subjects (25 subjects/arm) completed the study.
total of 51 subjects was completed the study. The potential subjects were screened as per the inclusion \& exclusion criteria only after obtaining written informed consent from the subjects. The adult female/male subjects were instructed to visit the facility as per the below visits.
- Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluations
- Visit 02 (Day 28): Treatment Period, Evaluations
- Visit 03 (Day 56): Evaluations, End of Study Visit Subjects were pre-screened by the screening department of NovoBliss Research. Subjects were called on the telephone by the recruiting department prior to the enrolment visit. Subjects were told during screening (prior to enrolment) not to wear any facial make-up or use any hair product on the study visit day.
Assessment of efficacy parameters before test treatment usage was done on day 1, and after test treatment usage was done on day 28, and day 56 as listed below.
- General Appearance of Hair i.e., hair volume, hair reflection, hair plasticity, hair density, hair smoothness, hair oiliness, hair shininess.
- General Appearance of Scalp i.e., Scalp itchiness, redness, scaling.
- CASLite Nova: Hair Density, Thickness, scalp condition
- Visioscan (C+K Instrument): Crow's feet area wrinkles, fine lines, skin texture - roughness,
- Skin Colorimeter CL 400: Right cheek skin colour evenness L*, a* b* and RGB, ITA Angle
- DermaLab®Combo - skin elasticity (Right cheek)
- MoitureMeterEPiD: Skin Hydration (Right cheek)
- Vapometer: Skin Barrier function - Transepidermal water loss (Right cheek)
- Physician Global Assessment for improvement in brittle nails - Day 01 and Day 56
- Serum Ferratin Biomarker test (Day 1 as baseline and Day 56)
- Digital Photographs: Facial photographs Before test treatment usage and after test treatment usage.
- Subjective Product Perception Assessment regarding the test product's effect on hair and skin firmness, appearance, nails etc
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A Proof-of-Concept, Placebo-Controlled, Safety, and Efficacy
| Arm | Type | Receives |
|---|---|---|
| SesZen-Bio™ | Experimental | Dietary Supplement: SesZen-Bio™SesZen-Bio™ is specially formulated for healthy hairs and healthy skin. Fortified with Sesbania Agati for 2X Hair Follicle Stimulation \& Hair Fall Control, to Promote Shiny Hair, biotin that Supports Hair Growth. |
| Placebo (Tapioca based starch Capsules) | Placebo comparator | Other: Placebotapioca starch, is a starchy white flour that has a slight sweet flavor to it and is prepared by extrusion and coating process. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Age: 30 to 55 years (both inclusive) at the time of consent.
- Sex: Healthy males and non-pregnant/non-lactating females.
- Females of childbearing potential must have a self-reported negative pregnancy test.
- Subjects are generally in good health.
- Subject with self-proclaimed nonpathological thin, dry and brittle hair.
Key exclusion criteria (17 listed)
- Subjects with a history of hair thinning/hair fall due to any clinically significant problems/s like anaemia, thyroid problems, etc.
- Subject has a history of allergy or sensitivity to the test treatment ingredients like sesbania agati and others etc.
- Subject has a history of any dermatological condition of the scalp other than hair loss and/or dandruff or active dermatological condition that might interfere with the clinical assessments (e.g. tattoos, eczema, psoriasis, acne, etc.).
- Subject has used any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks prior to the start or anticipates having to use at any point during the study.
- Subject has applied any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study.
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 |
|---|---|---|
| SesZen-Bio™mode of usage: 1 capsule in the morning and 1 capsule at night. administration: Oral Administration | Dietary supplement | SesZen-Bio™ |
| PlaceboMode of Usage: 1 capsule in the morning and 1 capsule at night. Route of Administration: Oral Administration | Other | Placebo (Tapioca based starch Capsules) |
Primary outcome
Change in Hair Density
Time frame: Day 01,Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
To evaluate the effectiveness of test treatment in terms of change in hair density between the treatment and placebo group by using CasaLiteNova (Instrumental Reading)
Change in Hair Thickness
Time frame: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
To evaluate the effectiveness of test treatment in terms of change in hair thickness between the treatment and placebo group by using CasaLiteNova (Instrumental Reading)
Change in Scalp Condition
Time frame: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
To evaluate the effectiveness of test treatment in terms of change in scalp condition between the treatment and placebo group by using CasaLiteNova (Instrumental Reading)
Change in Facial Wrinkle
Time frame: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
To evaluate the effectiveness of test treatment in terms of reducing facial wrinkle between the treatment and placebo group by using VisioScan (Instrumental Readings)
Change in Fine Lines
Time frame: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
To evaluate the effectiveness of test treatment in terms of reducing fine lines between the treatment and placebo group by using VisioScan (Instrumental Readings)
10 secondary outcomes
Change in Physician Global Assessment (PGA) scoring
Time frame: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
Change in Glogau Skin Age
Time frame: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
Change in Skin Colour
Time frame: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
Change in Skin Elasticity
Time frame: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
Change in Skin Hydration
Time frame: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
Change in Skin barrier Function
Time frame: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
Change in Serum Ferritin
Time frame: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
Change in brittle nails
Time frame: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
Noticeable Improvement in Facial Photograph
Time frame: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
Subjective Perception Questionnaires
Time frame: Day 01, Day 28 (+ 02 Days) and Day 56 (+ 02 Days)
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 5 Apr 2023.
- 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. Nayan K Patel, MBBS principal investigator
Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SesZen-Bio™ in people with Hair Thinning and Hair Brittle, 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 19 inclusion and 17 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 5 Apr 2023. 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. Some participants in this study may receive a placebo. 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?
Change in Hair Density (time frame: Day 01,Day 28 (+ 02 Days) and Day 56 (+ 02 Days)). The study lists 5 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 5 Apr 2023; AzTrials last refreshed its copy on 6 Nov 2026.