None listed
Conditions
Interventions
Intervention1: DRDC/SH/214: Vatika Dandruff Control Shampoo containing Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Guar Hydroxypropyltrimonium Chloride (Fabric Softeners), Prunus Amygdalus D
Sponsors
Dabur India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects (Female/Male) in generally good health. 2. Male and female subjects 18 to 40 years of age in th e ratio of 1:1. 3. Subjects should have an initial Area Severity Index of a least 32 and above at recruitment and baseline and should be clinically diagnosed as dandruff sufferers. 4. Length of the hair; for Males 7-9 cm and for females between shoulder to waist. 5. Subjects willing to give a written informed consent and come for regular follow up.
Exclusion criteria
Exclusion criteria: 1. Subjects with known allergies or sensitivities to ingredients contained in the test products. 2. Subjects with active dermatological conditions that can involve the scalp (eg.Psoriasis, exzema, ichthyosis, tinea capitis etc) other than the condition under study. 3. Chronic medication (e.g.antihistamines, antifungals, corticosteroids, topical steroids etc) that might influence the outcome of the study. 4. Subjects using systemic antifungal or corticosteroid therapy will be excluded unless such therapy has been discontinued for at least 30 days prior to the start of therapy. 5. Antipruritics (i.e antihistamines, anti-inflammatory agents, hydrocortinsone cream etc.) or topical antifungal therapy, selenium sulfide, zinc pyrithione, octopirox, salicylic acid, coal tar or corticosteroid therapy for the scalp/face must be discontinued for at least 14 days prior to the baseline. 6. Subjects with Atopic dermatitis and/or severe atopic dermatological background. 7. Subjects with prurigo nodularis and bleeding excoriations. 8. Subjects who have any pre-existing conditions that could interfere with the outcome of the study as determined by the investigator. Subjects with a concurrent disease that might place the subject at risk or prevent the subject from completing the study or an eye disease that might be subject to irritation from the shampoo. 9. Subjects who are pregnant or nursing (as confirmed by Urine test for the determination of Pregnancy). Continued use of birth control pills or implants and low therapeutic dosages of aspirin (325 mg or less) will be permitted and noted. 10. Subjects who are presently participating or participated in any other clinical study (i.e. dermal patch, use tests, investigational drug or devices etc.) 30 days before the start of the study. 11. Subjects viewed by the investigator as not being able to complete the study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| To evaluate overall safety of the shampoo over usageTimepoint: 0 Week, 2nd Week, 4th Week and 6th Week | — |
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Anti-dandruff shampoo on regular usage on healthy human.Timepoint: Week0,Week2,Week4,Week6 | — |
Countries
India
Contacts
Public ContactManmohan Sharma
Dabur India Ltd.
Outcome results
None listed