Seborrheic DermatitisNCT07063615
Safety and Efficacy of a Topical Cream in Mild-to-Moderate Seborrheic Dermatitis
A study testing Microbiome-Powered Cream in people with Seborrheic Dermatitis, run by NovoBliss Research Pvt Ltd at 1 site in India.
Trial summary
A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the safety and efficacy of scalp cream for Symptom Relief and Microbiome Balance in mild-moderate Seborrheic Dermatitis patients. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Seborrheic Dermatitis
- What is being tested?
- Microbiome-Powered Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteIndia
- Study dates
- 21 Jul 2025to 9 Feb 2026
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 20-55 years (both inclusive) at the time of consent.
- Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
- Females of childbearing potential must have a self-reported negative urine pregnancy.
- Subject is in good general health as determined by the Investigator on the basis of medical history.
- Patients must have a confirmed diagnosis of mild to moderate scalp seborrheic dermatitis, with an ASFS score of at least 16 at the time of screening.
- The severity grade will be evaluated by the dermatologist using the ASFS scale during the clinical study.
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- 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.
- 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.
- Patients are willing to give written informed consent and are willing to follow the study procedure.
- Patients who commit not to use any other medicated/ prescription shampoos/hair care products, any other hair growth products or hair colour or dye, other than the test treatment for the entire duration of the study.
- Patients who are having refrigerator at their home for storage of test treatment.
- Subject is willing and able to comply with study procedures, including all scheduled visits, treatment applications, and assessments.
- Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
- Subject must be able to understand and provide written informed consent to participate in the study.
Who cannot join
- Subject with known allergy or sensitization to test treatment ingredients.
- Subjects with a history of dermatological scalp conditions other than seborrheic dermatitis or dandruff (e.g., psoriasis, tinea capitis, lichen planopilaris).
- Subject who had taken topical treatment of dandruff for within preceding 4 weeks.
- Subject who had taken any systemic treatment for within preceding 3 months.
- Subject who have plans of shaving scalp hair during the study.
- Use of systemic or topical medications (e.g., corticosteroids, immunosuppressants, retinoids) known to affect skin or scalp within the past 3 months, or any medical history likely to interfere with study.
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- Subject has any concurrent skin disease.
- History of alcohol or drug addiction.
- Subjects with an allergy to dairy products.
- Subjects with a history or current presentation of visibly inflamed, infected, or severely irritated scalp, or known sensitivity to topical or cosmetic products.
- Pregnant or breast feeding or planning to become pregnant during the study period.
- Use of antibiotics, antifungal medications, or oral/topical probiotics within the past 4 weeks
- History of chronic illness which may influence the cutaneous state.
- Subject have participated any clinical research study related to hair care products within past 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Scalp Cream for Symptom Relief and Microbiome Balance in Mild-moderate Seborrheic Dermatitis Patients.
A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the safety and efficacy of scalp cream for Symptom Relief and Microbiome Balance in mild-moderate Seborrheic Dermatitis patients.
Read the detailed description
Thirty-four participants were randomized: 22 to the treatment group and 12 to the placebo group. Thirty-two participants completed the study: 20 treatment and 12 placebo. Two participants in the treatment group were lost to follow-up. Treatment was applied to affected scalp areas and, where applicable, other seborrheic dermatitis-affected sebum-rich sites, including the hairline/forehead, postauricular area, and neck/nape. Safety and tolerability were assessed throughout the 60-day treatment period by monitoring adverse events.
- Conditions
- Seborrheic Dermatitis
- Being tested
- Microbiome-Powered Cream, Placebo Hair Cream
- Medical subject headings
- Dermatitis, Seborrheic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiome-Powered CreamOther
Mode of Usage: Apply a generous amount of the cream to the affected area of the scalp. Gently part the hair using a wide-tooth comb or your fingertips to ensure direct contact with the scalp. Extend slightly beyond affected areas. Massage the cream gently into the skin until fully absorbed. Do not rinse off after application. Frequency: Apply twice daily - once after the morning shower and once before bedtime. Route of Administration: Topical Note For best results, the cream should be applied within 5 minutes of towel drying, while the scalp is slightly damp and soft. At night, ensure the cream is fully absorbed before lying down to avoid transfer to bedding materials like pillows or sheets.
Placebo Hair CreamOther
Mode of Usage: Apply a generous amount of the cream to the affected area of the scalp. Gently part the hair using a wide-tooth comb or your fingertips to ensure direct contact with the scalp. Extend slightly beyond affected areas. Massage the cream gently into the skin until fully absorbed. Do not rinse off after application. Frequency: Apply twice daily - once after the morning shower and once before bedtime. Route of Administration: Topical Note For best results, the cream should be applied within 5 minutes of towel drying, while the scalp is slightly damp and soft. At night, ensure the cream is fully absorbed before lying down to avoid transfer to bedding materials like pillows or sheets.
| Study group | Role | What they receive |
|---|---|---|
| Microbiome-Powered Cream | Experimental | Mode of Usage: Apply a generous amount of the cream to the affected area of the scalp. Gently part the hair using a wide-tooth comb or your fingertips to ensure direct contact with the scalp. Extend slightly beyond affected areas.
Massage the cream gently into the skin until fully absorbed. Do not rinse off after application.
Frequency: Apply twice daily - once after the morning shower and once before bedtime.
Route of Administration: Topical Note For best results, the cream should be applied within 5 minutes of towel drying, while the scalp is slightly damp and soft. At night, ensure the cream is fully absorbed before lying down to avoid transfer to bedding materials like pillows or sheets. Receives: Other: Microbiome-Powered Cream |
| Placebo Hair Cream | Placebo comparator | Mode of Usage: Apply a generous amount of the cream to the affected area of the scalp. Gently part the hair using a wide-tooth comb or your fingertips to ensure direct contact with the scalp. Extend slightly beyond affected areas.
Massage the cream gently into the skin until fully absorbed. Do not rinse off after application.
Frequency: Apply twice daily - once after the morning shower and once before bedtime.
Route of Administration: Topical Note For best results, the cream should be applied within 5 minutes of towel drying, while the scalp is slightly damp and soft. At night, ensure the cream is fully absorbed before lying down to avoid transfer to bedding materials like pillows or sheets. Receives: Other: Placebo Hair Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effectiveness of the test treatments by assessing the change in Adherent Scalp Flaking Score (ASFS) from baseline, both within treatment group and between treatment groups.
ASFS scale Mild: 16-24, Moderate :25-34, Severe : 35-80, eight scalp zones were each graded from 0-10 and summed to produce a total score from 0-80. ASFS showed XX% improvement
Measured: baseline on Day 01 and post usage of test treatment on Day 30 (+2 Days), Day 60 (+2 Days)
To evaluate the effectiveness of the test treatment by assessing the change in flake coverage for quantification of adherent flakes from baseline, both within treatment group and between treatment groups.
change in flake coverage using CASLiteNova from 8 parts of the scalp. Gives scalp condition images
Measured: from baseline on Day 01 and post usage of test treatment on Day 30 (+2 Days), Day 60 (+2 Days).
To evaluate the effectiveness of the test treatment by assessing reduction in itching from baseline, both within treatment group and between treatment groups.
reduction in itching using VAS scale for itching
Measured: from baseline on Day 01 and post usage of test treatment at T30 mins on Day 01, Day 30 (+2 Days), Day 60 (+2 Days).
To evaluate the effectiveness of the test treatment by assessing change in Scalp Erythema Index from baseline, both within treatment group and between treatment groups.
change in erythema Index using Mexameter® MX 18
Measured: from baseline on Day 01 and post usage of test treatment at T30 mins on Day 01, Day 30 (+2 Days), Day 60 (+2 Days).
Secondary outcomes (6)
To evaluate the effectiveness of the test treatment by assessing change in scalp barrier function from baseline, both within treatment group and between treatment groups.
change in scalp barrier function (Transepidermal Water loss) in g/m²/h using Tewameter® TM Hex
Measured: baseline on Day 01 and post usage of test treatment at T30 mins on Day 01, Day 30 (+2 Days), Day 60 (+2 Days).
To evaluate the effectiveness of the test treatment by assessing change in sebum production from baseline, both within treatment group and between treatment groups.
change in sebum production in μg/cm² using Sebumeter® SM 815
Measured: baseline on Day 01 and post usage of test treatment at T30 mins on Day 01, Day 30 (+2 Days), Day 60 (+2 Days).
To evaluate the effectiveness of the test treatment by assessing reduction in hair fall and non-adherent flake count from baseline, both within treatment group and between treatment groups.
reduction in hair fall and non-adherent flake count using 60 second hair combing test
Measured: baseline on Day 01 and post usage of test treatment on Day 30 (+2 Days), Day 60 (+2 Days).
To evaluate the effectiveness of the test treatment by assessing change in general appearance of scalp from baseline, both within treatment group and between treatment groups.
change in general appearance of scalp skin i.e. Itchiness, redness, roughness, and scaliness
Measured: baseline on Day 01 and post usage of test treatment at T30 mins on Day 01, Day 30 (+2 Days), Day 60 (+2 Days)
To evaluate the effectiveness of test treatment by assessing change in hair density and hair thickness from baseline, both within treatment group and between treatment groups.
assessing change in hair density (sqcm) and hair thickness (µm) using CASLiteNova
Measured: on Day 01 and post usage of test treatment on Day 30 (+2 Days), Day 60 (+2 Days).
To evaluate the effectiveness of the test treatment by assessing treatment perception questionnaire through Quality of Life Questionnaire 5-point likert scale and PGIC questionnaire
change in treatments perception questionnaire through Quality of Life Questionnaire using 5-point Likert scale and PGIC questionnaire
Measured: Day 01 and post usage of test treatment at T30 mins on Day 01, Day 30 (+2 Days), Day 60 (+2 Days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start21 Jul 2025
- Primary completion10 Jan 2026
- Study completion9 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seborrheic DermatitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Blossom Microbiotics LLC
- Responsible party
- Sponsor
- Investigators
- Dr Alka Makwana, Principal investigator, NovoBliss Research Private Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063615
- Sponsor's protocol ID
- NB250017-BM_1.0_30June
- Other IDs
- CTRI/2025/07/090946
- Status last verified
- Aug 2026
- First submitted
- 3 Jul 2025
- Last updated
- 10 Aug 2026
- 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 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Scalp Cream for Symptom Relief and Microbiome Balance in Mild-moderate Seborrheic Dermatitis Patients.
- ClinicalTrials.gov ID
- NCT07063615
- Acronym / sponsor ID
- NB250017-BM_1.0_30June
- Conditions
- Seborrheic Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Collaborators
- Blossom Microbiotics LLC
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- 10 Jan 2026 (actual)
- Study completion
- 9 Feb 2026 (actual)
- First posted
- 14 Jul 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.
A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the safety and efficacy of scalp cream for Symptom Relief and Microbiome Balance in mild-moderate Seborrheic Dermatitis patients.
Detailed description
Thirty-four participants were randomized: 22 to the treatment group and 12 to the placebo group. Thirty-two participants completed the study: 20 treatment and 12 placebo. Two participants in the treatment group were lost to follow-up. Treatment was applied to affected scalp areas and, where applicable, other seborrheic dermatitis-affected sebum-rich sites, including the hairline/forehead, postauricular area, and neck/nape. Safety and tolerability were assessed throughout the 60-day treatment period by monitoring adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microbiome-Powered Cream | Experimental | Other: Microbiome-Powered CreamMode of Usage: Apply a generous amount of the cream to the affected area of the scalp. Gently part the hair using a wide-tooth comb or your fingertips to ensure direct contact with the scalp. Extend slightly beyond affected areas. Massage the cream gently into the skin until fully absorbed. Do not rinse off after application. Frequency: Apply twice daily - once after the morning shower and once before bedtime. Route of Administration: Topical Note For best results, the cream should be applied within 5 minutes of towel drying, while the scalp is slightly damp and soft. At night, ensure the cream is fully absorbed before lying down to avoid transfer to bedding materials like pillows or sheets. |
| Placebo Hair Cream | Placebo comparator | Other: Placebo Hair CreamMode of Usage: Apply a generous amount of the cream to the affected area of the scalp. Gently part the hair using a wide-tooth comb or your fingertips to ensure direct contact with the scalp. Extend slightly beyond affected areas. Massage the cream gently into the skin until fully absorbed. Do not rinse off after application. Frequency: Apply twice daily - once after the morning shower and once before bedtime. Route of Administration: Topical Note For best results, the cream should be applied within 5 minutes of towel drying, while the scalp is slightly damp and soft. At night, ensure the cream is fully absorbed before lying down to avoid transfer to bedding materials like pillows or sheets. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Age: 20-55 years (both inclusive) at the time of consent.
- Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
- Females of childbearing potential must have a self-reported negative urine pregnancy.
- Subject is in good general health as determined by the Investigator on the basis of medical history.
- Patients must have a confirmed diagnosis of mild to moderate scalp seborrheic dermatitis, with an ASFS score of at least 16 at the time of screening.
Key exclusion criteria (14 listed)
- Subject with known allergy or sensitization to test treatment ingredients.
- Subjects with a history of dermatological scalp conditions other than seborrheic dermatitis or dandruff (e.g., psoriasis, tinea capitis, lichen planopilaris).
- Subject who had taken topical treatment of dandruff for within preceding 4 weeks.
- Subject who had taken any systemic treatment for within preceding 3 months.
- Subject who have plans of shaving scalp hair 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 |
|---|---|---|
| Microbiome-Powered CreamMode of Usage: Apply a generous amount of the cream to the affected area of the scalp. Gently part the hair using a wide-tooth comb or your fingertips to ensure direct contact with the scalp. Extend slightly beyond affected areas. Massage the cream gently into the skin until fully absorbed. Do not rinse off after application. Frequency: Apply twice daily - once after the morning shower and once before bedtime. Route of Administration: Topical Note For best results, the cream should be applied within 5 minutes of towel drying, while the scalp is slightly damp and soft. At night, ensure the cream is fully absorbed before lying down to avoid transfer to bedding materials like pillows or sheets. | Other | Microbiome-Powered Cream |
| Placebo Hair CreamMode of Usage: Apply a generous amount of the cream to the affected area of the scalp. Gently part the hair using a wide-tooth comb or your fingertips to ensure direct contact with the scalp. Extend slightly beyond affected areas. Massage the cream gently into the skin until fully absorbed. Do not rinse off after application. Frequency: Apply twice daily - once after the morning shower and once before bedtime. Route of Administration: Topical Note For best results, the cream should be applied within 5 minutes of towel drying, while the scalp is slightly damp and soft. At night, ensure the cream is fully absorbed before lying down to avoid transfer to bedding materials like pillows or sheets. | Other | Placebo Hair Cream |
Primary outcome
To evaluate the effectiveness of the test treatments by assessing the change in Adherent Scalp Flaking Score (ASFS) from baseline, both within treatment group and between treatment groups.
Time frame: baseline on Day 01 and post usage of test treatment on Day 30 (+2 Days), Day 60 (+2 Days)
ASFS scale Mild: 16-24, Moderate :25-34, Severe : 35-80, eight scalp zones were each graded from 0-10 and summed to produce a total score from 0-80. ASFS showed XX% improvement
To evaluate the effectiveness of the test treatment by assessing the change in flake coverage for quantification of adherent flakes from baseline, both within treatment group and between treatment groups.
Time frame: from baseline on Day 01 and post usage of test treatment on Day 30 (+2 Days), Day 60 (+2 Days).
change in flake coverage using CASLiteNova from 8 parts of the scalp. Gives scalp condition images
To evaluate the effectiveness of the test treatment by assessing reduction in itching from baseline, both within treatment group and between treatment groups.
Time frame: from baseline on Day 01 and post usage of test treatment at T30 mins on Day 01, Day 30 (+2 Days), Day 60 (+2 Days).
reduction in itching using VAS scale for itching
To evaluate the effectiveness of the test treatment by assessing change in Scalp Erythema Index from baseline, both within treatment group and between treatment groups.
Time frame: from baseline on Day 01 and post usage of test treatment at T30 mins on Day 01, Day 30 (+2 Days), Day 60 (+2 Days).
change in erythema Index using Mexameter® MX 18
6 secondary outcomes
To evaluate the effectiveness of the test treatment by assessing change in scalp barrier function from baseline, both within treatment group and between treatment groups.
Time frame: baseline on Day 01 and post usage of test treatment at T30 mins on Day 01, Day 30 (+2 Days), Day 60 (+2 Days).
To evaluate the effectiveness of the test treatment by assessing change in sebum production from baseline, both within treatment group and between treatment groups.
Time frame: baseline on Day 01 and post usage of test treatment at T30 mins on Day 01, Day 30 (+2 Days), Day 60 (+2 Days).
To evaluate the effectiveness of the test treatment by assessing reduction in hair fall and non-adherent flake count from baseline, both within treatment group and between treatment groups.
Time frame: baseline on Day 01 and post usage of test treatment on Day 30 (+2 Days), Day 60 (+2 Days).
To evaluate the effectiveness of the test treatment by assessing change in general appearance of scalp from baseline, both within treatment group and between treatment groups.
Time frame: baseline on Day 01 and post usage of test treatment at T30 mins on Day 01, Day 30 (+2 Days), Day 60 (+2 Days)
To evaluate the effectiveness of test treatment by assessing change in hair density and hair thickness from baseline, both within treatment group and between treatment groups.
Time frame: on Day 01 and post usage of test treatment on Day 30 (+2 Days), Day 60 (+2 Days).
To evaluate the effectiveness of the test treatment by assessing treatment perception questionnaire through Quality of Life Questionnaire 5-point likert scale and PGIC questionnaire
Time frame: Day 01 and post usage of test treatment at T30 mins on Day 01, Day 30 (+2 Days), Day 60 (+2 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 10 Aug 2026.
- 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 Alka Makwana principal investigator
NovoBliss Research Private Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microbiome-Powered Cream in people with Seborrheic Dermatitis, 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 14 inclusion and 14 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 10 Aug 2026. 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?
To evaluate the effectiveness of the test treatments by assessing the change in Adherent Scalp Flaking Score (ASFS) from baseline, both within treatment group and between treatment groups. (time frame: baseline on Day 01 and post usage of test treatment on Day 30 (+2 Days), Day 60 (+2 Days)). The study lists 4 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 10 Aug 2026.