None listed
Conditions
Interventions
Intervention1: AntiDandruff Shampoo-VB-3222: The test shampoo has been used for weekly three times for 3 weeks during treatment phase. Duration- 3 weeks Frequency-weekly three times dose- 10 ml (Male:
Sponsors
Vyome Biosciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female subjectsâ?? in general good health. 2.Subjects in the age group 18-65 years (both the ages inclusive). 3.Subjects with at least moderate dandruff at baseline (score of >= 24) as per ASFS. Each zone (8) will have a score of 2 or more. 4.Subjects with the score of at least 1 for pruritus as per Investigator global assessment (IGA). 5.Subjects willing to refrain from any use of anti-dandruff shampoo or antidandruff treatment during the study duration. 6.Female subjects of child bearing potential willing to use effective birth control during the study duration and following 30 days after their final study visit. 7.Subjects willing to give a voluntary written informed consent and agree to come for a regular follow up visit. 8.Subjects willing to abide by and comply with the study protocol. 9.Subjects who have not participated in a similar investigation in the past four weeks.
Exclusion criteria
Exclusion criteria: 1.Subjects having any scalp condition that would interfere with the diagnosis or assessment of dandruff (e.g., active scalp disorder such as psoriasis, DLE, SLE, lichen planus, lichen planopilaris and Eczema). 2.Female subjects who are pregnant or lactating or nursing as established by medical history or planning to become pregnant during the study period. 3.Subjects with the history of or presence of significant skin disorder (such as but not limited to severe seborrheic dermatitis, atopic dermatitis, psoriasis or skin cancer) which will interfere with the test readings. 4.Subjects with history of allergy to soaps, lotions, shampoos, topical drugs of same class as the study medication. 5.Subjects with history of hypersensitivity or allergy to zinc pyrithione and / or any component of the test product. 6.Subjects on Topical steroids Topical antifungal treatments including OTC preparations Topical anti-inflammatory agents Topical antibiotics Antidandruff or antiseborrheic topical treatment (e.g., antidandruff shampoos, anti-seborrheic shampoos and coal tar preparations). 7.Systemic treatment which may modify the cutaneous state on the day of inclusion or in the previous 30 days, including retinoid therapy. 8.Chronic illness which may influence the cutaneous state. 9.Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious medical illness. As per investigatorâ??s discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Reduction in mean adherent dandruff score (ASFS) post application of VB-3222 at Day 21 in comparison to baseline 2.Reduction in mean score of pruritis (IGA) post application of VB-3222 at Day 21 in comparison to baseline Timepoint: 42 days for each subject. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Reduction in mean adherent dandruff score (ASFS) and pruritis (IGA) post application of VB-3222, with reference to number of washes, at all time points in comparison to baseline. 2.Reduction in mean flaking score post application of VB-3222, with reference to number of washes, at all time points in comparison to baseline. 3.Improvement in subject satisfaction including hair sensorial evaluation as assessed by scalp related Quality Of Life Index on Day 21 in comparison to baseline. Timepoint: 42 days for each subject.;4.Improvement of scalp condition evaluated by comparative assessment at time point day 21 in comparison to baseline. 5.To assess the safety and tolerability post application of VBthroughout the study. Timepoint: 42 days for each subject | — |
Countries
India
Contacts
Public ContactDr Mukesh Ramnane
MS Clinical Rsearch Pvt Ltd
Outcome results
None listed