ClinicalTrials.gg
CompletedNCT07063615Updated Aug 10, 2026

Safety and Efficacy of a Topical Cream in Mild-to-Moderate Seborrheic Dermatitis

An interventional study of Microbiome-Powered Cream and Placebo Hair Cream in Seborrheic Dermatitis, sponsored by NovoBliss Research Pvt Ltd. Completed at 1 site in India. Open to participants aged 20 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by NovoBliss Research Pvt Ltd · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Seborrheic Dermatitis

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03

In context

Dermatitis, Seborrheic

58 studies on the registry are indexed under Dermatitis, Seborrheic; 7 are open to participants now.

This study's enrollment of 34 is below the median of 77 across 47 interventional studies indexed under Dermatitis, Seborrheic.

Browse Dermatitis, Seborrheic studies →

Lead sponsor

NovoBliss Research Pvt Ltd is the lead sponsor of 47 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 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.
  • Subject is able to remain on stable doses of 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 for at least 1 year or have had a tubal ligation.
  • Patients are willing to give written 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.

Exclusion criteria

Exclusion Criteria:

  • 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., , , retinoids) known to affect skin or scalp within the past 3 months, or any medical history likely to interfere with study.
  • 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.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Microbiome-Powered Cream

    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.

    Other: Microbiome-Powered Cream

  • Placebo comparator
    Placebo Hair Cream

    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.

    Other: Placebo Hair Cream

Interventions

  • OtherMicrobiome-Powered Cream

    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.

  • OtherPlacebo Hair Cream

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: baseline on Day 01 and post usage of test treatment on Day 30 (+2 Days), Day 60 (+2 Days)

  2. 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

    Time frame: from baseline on Day 01 and post usage of test treatment on Day 30 (+2 Days), Day 60 (+2 Days).

  3. 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

    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).

  4. 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

    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).

Secondary outcomes

  1. 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

    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).

  2. 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

    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).

  3. 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

    Time frame: baseline on Day 01 and post usage of test treatment on Day 30 (+2 Days), Day 60 (+2 Days).

  4. 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

    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)

  5. 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

    Time frame: on Day 01 and post usage of test treatment on Day 30 (+2 Days), Day 60 (+2 Days).

  6. 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

    Time frame: Day 01 and post usage of test treatment at T30 mins on Day 01, Day 30 (+2 Days), Day 60 (+2 Days).

Other outcomes

  1. To evaluate the effectiveness of the test treatment by assessing change in scalp microbiome from baseline, both within treatment group and between treatment groups.

    longitudinal changes in scalp microbiome composition and host response by collecting BD swabs and FLOQ swabs

    Time frame: BD eSwabs: Day 1, Day 30 and Day 60 FLOQ biomarker swabs: Day 1 and Day 60 only

07

Study locations

1 site
  • NovoBliss Research Private Limited
    Ahmedabad, Gujarat 382481, India
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2025 to primary completion in Jan 2026, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 3, 2025
First posted
Jul 14, 2025
StartActual
Jul 21, 2025
Primary completionActual
Jan 10, 2026
CompletionActual
Feb 9, 2026
Last update
Aug 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07063615
Lead sponsor
NovoBliss Research Pvt Ltd
Collaborators
Blossom Microbiotics LLC
Responsible party
Sponsor
First posted
Jul 14, 2025
Start date
Jul 21, 2025
Primary completion
Jan 10, 2026
Completion
Feb 9, 2026
Last update
Aug 10, 2026

Study contacts

Dr Alka Makwana
principal investigator · NovoBliss Research Private Limited

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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