MedPath

A clinical study to evaluate Skin Health Benefits of Skin-cera™ in Healthy Human Volunteers

Phase 3
Registration Number
CTRI/2024/06/068757
Lead Sponsor
Vidya Herbs Pvt Ltd.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Subjects presenting with dry skin and signs of photoaging.

2. Subjects not undergoing any supplementation for skin health.

3. Subject has not participated in a similar clinical investigation in the past three months.

4. Subject who is willing to abstain from using any fairness product, sunscreens, natural/ ayurvedic treatments or oral skin supplements or other home remedies and also willing to abstain from undergoing any facial treatments such as facial masks, packs, bleaching, etc either at home or at parlour during the entire study course.

5. In case of having used skin treatment in the near past, should be willing to undergo a wash out period of 1 week, wherein they should abstain from applying any product other than the provided cleanser on face.

6. Male subjects who are willing to maintain their facial skin condition as shaved at baseline and during the entire study course.

7. Female subjects of reproductive age group have negative urine pregnancy test (UPT) at screening visit.

8. Subject willing to give written informed consent and comply with the study procedures.

Exclusion Criteria

1. Subject with a medical history of disease or condition or a concurrent illness or pre-existing or dormant dermatologic condition that could interfere with the study results.

2.Subject who has used any systemic medication within past 4 weeks or any topical facial medication within 2 weeks prior to study commencement, which could compromise the study.

3.Subject with excessive facial hair or scars, which could interfere with evaluation.

4.Subject with a history of having used a similar product during or since 1 week prior to the scheduled study commencement.

5.Subject who is currently pregnant or nursing or contemplating pregnancy during the study course.

6.Subjects will history of drug or alcohol abuse or chronic smoking.

7.Subjects allergic to herbal products or any component of the study product

8.Known HIV or Hepatitis B positive or any other immuno-compromised state

9.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study

10.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath