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To Assess the skin irritation potential of Non-Hydroquinone night cream,HA Face Serum,Moisturizer,Hair Strengthening Shampoo,Conditioner,Hair Oil, by repeated application of patches on human ski

Phase 3
Registration Number
CTRI/2023/07/054853
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
Inclusion Criteria

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 intact skin on the proposed application site; dorsum (scapular region)

4.Fitzpatrick photo type I to IV skin type

5.Willingness to participate as evidenced by voluntary written informed consent

Exclusion Criteria

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 open sores, pimples, or cysts at the application site.

5.Active dermatosis (local or disseminated) that might interfere with the results of the study.

6.Considered immune compromised.

7.History of 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 atop, 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 patches

16.History of sensitization in a previous patch 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
NameTimeMethod
To ascertain the irritation potential of 3 <br/ ><br>investigational products after removal of <br/ ><br>occlusive patch after every 24 (±2) hours in <br/ ><br>sequential manner for 37 days which includes 18 <br/ ><br>days of Induction phase, 14 days Resting phase <br/ ><br>& 5 days of Challenge phase to the skin of <br/ ><br>healthy volunteers.Timepoint: D1 to D18, 18 days of Induction phase <br/ ><br>D19 to D32, 14 days of resting phase <br/ ><br>D33 to D36, 5 days of Challenge Phase
Secondary Outcome Measures
NameTimeMethod
To evaluate the general safety of 3 <br/ ><br>investigational products. <br/ ><br>Timepoint: Assessed during, D1 to D18, 18 days of <br/ ><br>Induction phase <br/ ><br>D19 to D32, 14 days of resting phase <br/ ><br>D33 to D36, 5 days of Challenge Phase
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