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Dermatological safety of investigational product on healthy human subjects.

Evaluation of dermatological safety and hypo-allergenicity of investigational products by Human Repeat Insult Patch Test (HRIPT) on healthy human volunteers with sensitive skin - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089489
Enrollment
50
Registered
2025-06-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

None listed

Interventions

Intervention1: SHRUMEI Dark Spot Corrector serum: 40 l of investigational product(without dilution) was applied on the precut filter paper placedinside the allotted Derma proof Aluminium Finn cham

Sponsors

Dr. Anil kumar, Director Neeta life sciences Pvt. Ltd,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Voluntary men and women between 18 and 65 years. Photo type III to V. Self-declaration of subject with sensitive skin. Having apparently healthy skin on test area. For whom the investigator considers that the compliance will be correct. Cooperating, informed of the need and duration of the examinations and ready to comply with protocol procedures. Having signed a Consent Form. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study. Willingness to avoid excessive water contact (for example swimming) or activity which causes excessive sweating (that is exercise, sauna ), during the course of the study. Should be able to read and write (in English, Hindi or local language). Having valid proof of identity and age.

Exclusion criteria

Exclusion criteria: Pregnant and nursing mothers Scars, excessive terminal hair or tattoo on the studied area. Henna tattoo anywhere on the body (in case of studies involving hair dyes). Dermatological infection pathology on the level of studied area. Exclusion Criteria Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial. Hypersensitivity, allergy antecedent (to any cosmetic product,raw material or hair dye). Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures. Chronic illness which may influence the outcome of the study. 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).

Design outcomes

Primary

MeasureTime frame
1.To determine the irritation and/or sensitization potential of a test material 2.In support of sensitive skin claims and supporting evidence for hypoallergenicity claims after repeated application under occlusive or semi-occlusive patches to the skin of human subjects.Timepoint: Day 1 to Day 40

Secondary

MeasureTime frame
Incidence & rate of adverse eventsTimepoint: Day 1 to Day 40

Countries

India

Contacts

Public ContactDr Ashok Godavarthi

Radiant Research Services Pvt Ltd.

surya.ashok@gmail.com09880999297

Outcome results

None listed

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