To assess the test Moisturizer is not known to produce pimples/Acne after applicatio
- Registration Number
- CTRI/2023/07/055220
- Lead Sponsor
- Skinovate Laser & Cosmetic Surgery center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Healthy male and female volunteers aged 18 to 65 with no active dermatological conditions
2. Good general and mental health with, in the opinion of the investigator or medically qualified designee with no clinically significant and relevant abnormalities in medical history or upon physical examination
3. Subjects who have normal, dry, oily, combination (mixed) type of skin types.
4. Fitzpatrick photo type I to IV skin type
5. Willingness to participate as evidenced by voluntary written informed consent
1. Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
2. Women who are breast-feeding
3. Any history of significant dermatological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction.
4. Presence of Acne, TLC more than 10 (Inflammatory & Non-Inflammatory).
5. Active dermatosis (local or disseminated) that might interfere with the results of the study.
6. Considered immune compromised.
7. History of photosensitivity, & or diseases aggravated or triggered by ultraviolet radiation.
8. Participants with dermatographism.
9. Currently using any medication which in the opinion of the investigator, may affect the evaluation of the study product, or place the subject at undue risk.
10. Use of the following topical or systemic medications: immunosuppressants, antihistamines, nonhormonal anti-inflammatory drugs, and corticosteroids up to 2 weeks before screening visit.
11. Oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit
12. Intention of being vaccinated during the study period or vaccination within 3 weeks of the screening visit.
13. Currently receiving allergy injections, or due to receive an injection within 7 days prior to Visit1, or expects to begin injections during study participation
14. Previous history of atopic dermatitis, allergic reactions, irritation or intense discomfort feelings to topical use products, cosmetics, or medication
15. Known or suspected intolerance or hypersensitivity to any of the study
materials (or closely related compounds) or any of their stated ingredient including any component of the study product.
16. History of sensitization in a previous study.
17. Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30days of the screening visit
18. Recent history (within the last years) of alcohol or other substance abuse
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Increase, decrease or no change in total <br/ ><br>lesion count after regular use of SKINOVATE - - Moisturizer. <br/ ><br>2. Assess the irritation potential of the test <br/ ><br>product.Timepoint: 28 days study 36 subjects to check products <br/ ><br>comedogenicity & skin irritancy on D1 D14 <br/ ><br>D28
- Secondary Outcome Measures
Name Time Method To evaluate the general safety investigational <br/ ><br>products by evaluating signs & symptoms of <br/ ><br>irritation.Timepoint: 28 days study 36 subjects to check any adverse <br/ ><br>events on D1 D14 D28