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Safety Testing of papaya seed oil by Patch test

EVALUATION OF DERMATOLOGICAL SAFETY OF PAPAYA SEED OIL BY PRIMARY IRRITATION PATCH TEST ON HEALTHY HUMAN VOLUNTEERS OF VARIED SKIN TYPES

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/06/043165
Enrollment
26
Registered
2022-06-10
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: Papaya Seed Oil: Approximately 40 �µl/0.04 ml of product will be applied on the investigational area i.e. on back between shoulders and waist on day 1 which needs to be retained for 2

Sponsors

Dole Asia Holdings Pte Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient must meet all of the following criteria in order to be included in the study. 1. Subject in generally good health. 2. Subject between the age group of 18 and 55 years. 3. Subject has not participated in a similar clinical investigation in the past four weeks. 4. Subject willing to abstain from using any product, besides the provided product during the entire study course. 5. Subject willing to visit the site at specified frequencies for periodic evaluations. 6. Subject willing to comply with study specific requirements. 7. Subject willing to give a written informed consent and come for regular observation

Exclusion criteria

Exclusion criteria: All subjects will be excluded from the study if they meet any of the following exclusion criteria: 1. A known history or present condition of allergic response to any Cosmetic products. 2. Subject with known allergy/ sensitivity to cosmetic products or fragrance and without any skin allergies infections. 3. Subject under any dermatological treatment / prescribed medications. 4. Skin disease (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations on the scalp), which would interfere with the test readings. 5. Any cutaneous conditions on test site (scars, moles, papules etc.) 6. On medications (e.g. steroids or antihistamines), which would compromise the study. 7. Currently or has been undergoing dermatologist facial treatments or procedures within the last 1 month.

Design outcomes

Primary

MeasureTime frame
Safety assessment of investigational products for irritation potential using Draize scale after patch removal at 0 hours(day 3),24 hours(day 4) and 7 days post patch removal.Timepoint: Safety assessment of investigational products for irritation potential using Draize scale after patch removal at 0 hours(day 3),24 hours(day 4) and 7 days post patch removal.

Secondary

MeasureTime frame
NilTimepoint: Nil

Countries

India

Contacts

Public ContactPurushotam

Auriga Research Private Limited

dr.poojaggarwal@gmail.com01244006445

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026