Health Condition 1: L219- Seborrheic dermatitis, unspecified
Conditions
Interventions
Intervention1: Anti-Dandruff Shampoo containing ScalpCleanse™: Apply approximately 10-12 ml of shampoo per wash three times a week for four weeks(28 to 30 days) while cleansing your hair.
Control Inte
Sponsors
Amvigor Organics Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and females aged 18 to 55 years (both inclusive);2.Subjects clinical diagnosis of dandruff of the scalp (combined score for scaling and erythema lies between 2 and 4) during screening.3.Willingness to complete questionnaires, records, and diaries associated with the study and to complete all visits;4.Provided voluntary, written informed consent to participate in the study;5.Willing to refrain from the use of all other topical medications that would affect the results of the trial, including medicated shampoos or oils or antibiotics or oral antifungal agents during the treatment and relapse periods.
Exclusion criteria
Exclusion criteria: 1.History or presence of compromising dermatosis elsewhere on the skin 2.History or presence of Parkinsons disease, HIV, infections or disorders of the central nervous system 3.Have used an antidandruff agent in the past 14 days 4.Presence of any skin condition that would interfere with the diagnosis or assessment of dandruff, e.g., psoriasis, acne, atopic dermatitis 5.Use within 2 weeks prior to baseline of any treatment that would affect the results of the trial, including a) topical steroids, b) topical retinoids, c) topical anti-inflammatory agents, d) topical antibiotics e) oral antifungal agents or f) topical treatment of adherent dandruff (e.g., coal tar preparation, antidandruff shampoo or oils or gels or creams or conditioners) antihistamines. 6.Participation in other clinical trials in last 90 days prior to screening. 7.Females who are pregnant and have a positive urine pregnancy test or planning to be pregnant or lactating or not using reliable methods of contraception; 8.Any condition that could, in the opinion of the investigator, preclude the participants ability to complete the study or that may confound study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Assessment of change in score for scaling adherent and non-adherent dandruff compared to the marketed product. 2. Assessment of changes in the degree of erythema using a 4-point scale compared to the marketed product. 3. Change in appearance of dandruff scaling compared to the marketed product by using Phototrichogram. 4. Assessment of sebum production compared to the marketed product by using sebumeter. Timepoint: 1. At baseline, day 3, day 9, day 15, and day 30. 2. At screening, baseline, day 3 day 9, day 15, and day 30. 3. At baseline, day 3, day 15, and day 30. 4. At baseline, day 15, and day 30. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of degree of scalp itching compared to the marketed product using a 4-point scale. 2. Subjective self-assessment questionnaire to assess patient perception of scalp and hair health and the efficacy of products according to a 5-point scale compared to the marketed product. 3. Assessment of scalp condition for in-use tolerance with respect to dryness compared to the marketed product using a 4-point scale. 4. Assessment of subject perception of the in-use tolerance of products which will capture reactions like tingling, burning sensation, allergic reactions, or eye stinging compared to the marketed product using a 4-point scale. Timepoint: 1. From screening to day 30. 2. At baseline, day 3, day 9, day 15, day 21, and day 30. 3. From screening to day 30. 4. From day 3 to day 30. | — |
Countries
India
Contacts
Public ContactDr Gayatri Ganu
Amvigor Organics Pvt. Ltd.
Outcome results
None listed