To check irritation potential of the given samples (Patch test)

To Evaluate The Dermatological Safety Of The Investigational Products By Primary Irritation Patch Test On Healthy Human Volunteers With Sensitive Skin Type.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/11/022065

Enrollment

Registered

2019-11-19

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Rinse off - 114-59: Day 1 (day of patch application), Day 2 (0 hrs. of Patch Removal i.e. 24 hrs. of patch application), Day 3 (24 hrs. of patch removal) and Day 9 (1 week after patch r

Eligibility

Inclusion criteria

Inclusion criteria: 1. Volunteer (female/ male) in generally good health. 2. Volunteer between the ages of 18 and 65 years. 3. Volunteer has not participated in a similar clinical investigation in the past four weeks. 4. Volunteer willing to give a written informed consent and come for regular observation. 5. Subjects scoring greater than 30 for Section 2- Sensitive Vs Resistant skin in modified Dr. BaumannÃ¢â?¬•s sensitive skin Questionnaire. 6. Subject identified to have sensitive skin on basis of DermatologistÃ¢â?¬•s assessment of skin with fine texture and closeness of blood vessels to the surface.

Exclusion criteria

Exclusion criteria: 1. A known history or present condition of allergic response to any cosmetic products. 2. Skin disease (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations on the scalp), which would interfere with the test readings. 3. Subjects under chronic medication (e.g. Antihistamines, Antifungals, Corticosteroids, topical Steroids, etc.) that might influence the outcome of the study. 4. Pregnant or lactating females. 5. Subjects participating in any other cosmetic or therapeutic trial.

Design outcomes

Primary

Measure	Time frame
Irritation potentialTimepoint: first observation will be made at 30 minutes of patch removal (0 hr. observation). The further observations will be at 24 hrs and 1 week of patch removal	—

Secondary

Measure	Time frame
investigational products to be tested for irritancy testTimepoint: On each subjectÃ¢â?¬â?¢s back one patch of each investigational product will be applied on Day 1. This will be 9 days study. For all the products and positive control the subjects will be assessed by the study dermatologist on Day 1 (Day of patch application), Day 2 (0 hrs. of patch removal i.e. 24 hrs. of patch application), Day 3 (24 hrs. of patch removal) and Day 9 (1 week after patch removal).	—

Measure

Time frame

investigational products to be tested for irritancy testTimepoint: On each subjectÃ¢â?¬â?¢s back one patch of each investigational product will be applied on Day 1. This will be 9 days study. For all the products and positive control the subjects will be assessed by the study dermatologist on Day 1 (Day of patch application), Day 2 (0 hrs. of patch removal i.e. 24 hrs. of patch application), Day 3 (24 hrs. of patch removal) and Day 9 (1 week after patch removal).

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Countries

India

Contacts

Public ContactMs Meghana Surve

The KETÃ¢â?¬â?¢s, Scientific Research Centre

meghana@kelkarcosmetology.com02225639644

Outcome results