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Testing Skin Irritation Using Patch Test in Healthy Adults

Evaluation of Dermatological safety of Test Products by Primary Irritation Patch Test on Healthy Human Volunteers of All Skin Types - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/087970
Enrollment
24
Registered
2025-05-30
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

None listed

Interventions

Intervention1: Trichup Pro Scalp Nourishing Hair Oil: 1. Helianthus Annuus Seed Oil 2. BHT 3.Ocimum basilicum Oil 4. Citrus medica acida peel Oil 5. Melaleuca alternifolia leaf Oil 6. Tocopherol 7. Me

Sponsors

Vasu Healthcare Pvt. Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Voluntary men and women ratio of 1:1 between 18 and 65 years. 2. Having apparently healthy skin in test area as assessed by dermatological examination. 3. For whom the investigator considers that the compliance will be correct. 4. Subjects with normal, dry, oily and combination skin in approximately equal ratio. 5. The subject is informed of the need and duration of the examination and is ready to comply with protocol requirements. 6. Subject is ready to sign the informed consent form. 7. Subjects willingness to avoid intense UV exposure on test sites (sun or artificial UV) during the study. 8. Subjects willingness to avoid excessive water contact (e.g. swimming) or activity which causes excessive sweating (e.g. exercise, sauna) during the study. 9. Having valid proof of identity and age. 10. Volunteers evaluated Fitzpatrick skin type 3 to 5 as per the Fitzpatrick scale (Appendix IV).

Exclusion criteria

Exclusion criteria: 1. Pregnant/nursing mothers. 2. Scars, acne, excessive terminal hair, or tattoos on the studied area. 3. Dermatological infection/pathology on level of studied area. 4. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye) 5. Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures. 6. Chronic illness, which may influence the outcome of the study. 7. Subjects on any medical treatment, either systemic or topical, which may interfere with the performance of the study treatment (presently or in the past 1 month). 8. Subject in an exclusion period or participating in another food, cosmetic, or therapeutic trial.

Design outcomes

Primary

MeasureTime frame
1. Change from irritation potential of the test products from baseline to post application measured using the mean irritation score. 2. Score of less than or equal to 2 on the Draize scale. Timepoint: Day 2, Day 3 and Day 9

Secondary

MeasureTime frame
1. Incidence of treatment-emergent adverse events (safety and tolerability)Timepoint: Day 2, Day 3 and Day 9

Countries

India

Contacts

Public ContactMeena Dalal

TrialGuna Private Limited

drsohanshetty@yahoo.co.in9448075762

Outcome results

None listed

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