A clinical study to evaluate the safety and efficacy of the test product in improving scalp health over 4 weeks in comparison to baseline.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- LiquidCubes InnoCommerce (LiquidCubes)
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- 1) Improvement of scalp health/condition and significant reduction of the total dandruff score, Non-Adherent and Adherent flakes score evaluated by Visual assessment.
Overview
Brief Summary
This 4-week monocentric clinical study aims to evaluate the effectiveness of three test products in improving scalp health. Ninety male participants, aged 18-45, will be divided across three test groups. During Visit 1 (screening), subjects will undergo acclimatization, and baseline assessments related to scalp health along with microbiome sampling and they will be instructed about the use of the test product. In Visit 2 (Week 2), product compliance will be checked, and similar assessments will be repeated. During Visit 3 (Week 4), final evaluations will be conducted, and the test products, diaries, and exit form will be collected.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Male
Inclusion Criteria
- •Male subjects in general good health with scalp conditions (Dry, Itchy, Irritated, Redness, Flaking) 2) Subjects in the age group 18-45 years (both ages inclusive).
- •Subjects with moderate flakes.
- •Subjects willing to give written informed consent and willing to abide by and comply with the study protocol.
- •Subjects willing to refrain from using any other product that can impact scalp health.
Exclusion Criteria
- •Subjects having any active scalp disease which may interfere with the study based on the dermatologist’s discretion.
- •Subjects who have taken chemotherapy for cancer in the 6 months prior to the start of the study.
- •Subjects who have undergone hair transplants.
- •A known history or present condition of allergic response/hypersensitivity to any hair or pharmaceutical products.
- •Subjects on oral medications like topical or systemic corticosteroids, anti-fungal, or antibiotics, or any prolonged use of non-steroidal anti-inflammatory, or anti-histaminic within 2 weeks prior to the study, undergoing any chemical hair salon treatment-straightening / perming/color/henna which will compromise the study.
- •Subjects participating in other similar trials within the last 2 weeks.
- •Subjects with any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, thyroid, hepatitis, severe anemia, serious disorder of the heart and respiratory apparatus or any other serious medical illness 8) Employees of MSCR or the sponsor.
Outcomes
Primary Outcomes
1) Improvement of scalp health/condition and significant reduction of the total dandruff score, Non-Adherent and Adherent flakes score evaluated by Visual assessment.
Time Frame: Baseline, week 2 and week 4
2) Reduction in oiliness and Improved scalp hydration by non-invasive instrumental assessment.
Time Frame: Baseline, week 2 and week 4
3) Efficacy of the test product in reducing flakes using the Visible Flake Assessment.
Time Frame: Baseline, week 2 and week 4
4) Change of microbiome of the scalp by product usage at week 4.
Time Frame: Baseline, week 2 and week 4
5) Improved scalp condition by microscopic imaging.
Time Frame: Baseline, week 2 and week 4
Secondary Outcomes
- 1) Improved scalp health by Subject self-assessment.(Baseline, week 2 and week 4)
Investigators
Dr Sharad Nadiga
MS Clinical research