Evaluate effect and safety Of VB-001, an Antidandruff Hair Oil Regime In Comparison With Head & Shoulders® Antidandruff Shampoo (P&G) Regime In Subjects With Moderate Adherent Dandruff Of The Scalp

Not Applicable

Completed

• Registration Number: CTRI/2013/01/003283
• Lead Sponsor: Vyome Biosciences Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2013-04-13
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 159

Inclusion Criteria

1. Healthy males or females aged >= 15 years and <= 65 with a clinical diagnosis of moderate adherent dandruff of the scalp.

2.Understand and willing to sign written informed consent in case of adults and written parental consent form and child assent form in case of children wherever applicable.

3. Must be willing and able to comply with protocol, including measures of subject compliance.

4. Must have active adherent dandruff of the scalp with a minimum score of 6 and not exceeding 14; baseline scaling scoring of at least 3 and not more than 4 of adherent flaking in at least one zone of the scalp (6 zones- 2 frontal, 2 parietal plus temporal and 2 occipital) .

5. Investigators global assessment (IGA) for pruritis score of at least 1.

6. Should not have used an antidandruff agent in the past 14 days.

7. Willing to refrain from use of all other topical medications that would affect the results of the trial, including medicated shampoos/oils or antibiotics, during the treatment and observation periods (from day 0 to day 14).

Exclusion Criteria

1. Pregnant or Lactating Women by history.

2. No history of overt bacterial, viral or fungal infection of the head/neck.

3. No history or presence of compromising dermatosis elsewhere on the skin.

4. No actinically damaged skin

5. Presence of any skin condition that would interfere with the diagnosis or assessment of adherent dandruff; e.g., psoriasis, acne, atopic dermatitis.

6. Clinically significant systemic disease (e.g., immunological deficiencies, AIDS, current malignancies, uncontrolled diabetes mellitus).

7. Use within 1 month prior to baseline of any treatment that would affect the results of the trial, including 1) systemic antifungals, 2) systemic steroids 3) systemic antibiotics 4) systemic anti-inflammatory agents or 5) cytostatic or immunomodulating drugs (e.g., cyclosporine, tacrolimus, pimecrolimus).

8. Use within 2 weeks prior to baseline of any treatment that would affect the results of the trial, including 1) topical steroids 2) topical retinoids 3) topical anti-inflammatory agents 4)topical antibiotics or 5) topical treatment of adherent dandruff (e.g., coal tar preparations, antidandruff shampoos/oils/gels/creams/conditioners 6) antihistamines.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate efficacy of VB-001, antidandruff hair oil regime in comparison with Head & Shoulders® Antidandruff Shampoo (P&G) regime in subjects with Moderate adherent dandruff of the scalp.Timepoint: 0,5 ,9,and 14 days

Secondary Outcome Measures

Name	Time	Method
To evaluate in use skin safety VB-001, antidandruff hair oil regime in comparison with Head & Shoulders® Antidandruff Shampoo (P&G) regime in subjects with Moderate adherent dandruff of the scalpTimepoint: 0,5 ,9,and 14 days