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Clinical Trials/CTRI/2025/04/084016
CTRI/2025/04/084016Not yet recruitingNot Applicable

A clinical study to evaluate the skin Sensitization potential of BTM Ventures Reginald Sunscreen on healthy human volunteers

Btm Ventures Pvt. Ltd.1 site in 1 country200 target enrollmentStarted: April 14, 2025Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
200
Locations
1
Primary Endpoint
Change in Skin Irritation Score-erythema & oedema
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

200 human volunteers are selected for the patch test done as per BIS 4011 for sensitization

The experiment is 40 days including Induction phase: 21 days Rest Phase: 14 days Challenge Phase: 5 days.

Guideline Followed: BIS 4011: for skin sensitization

  1. BTM Ventures Reginal Sunscreen

Study Design

Study Type
Interventional
Allocation
Not Applicable
Masking
Open Label

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Voluntary man or women between 18 and 65 years.
  • •Phototype III to V.
  • •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

  • •Pregnant or nursing mothers 2.Scars, excessive terminal hair or tattoo on the studied area 3.Henna tattoo anywhere on the body (in case of studies involving hair dyes) 4.Dermatological infection or pathology on the level of studied area 5.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye) 6.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures 7.Chronic illness which may influence the outcome of the study 8.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) 9.Subject in an exclusion period or participating in another food,cosmetic or therapeutic trial.

Outcomes

Primary Outcomes

Change in Skin Irritation Score-erythema & oedema

Time Frame: D2, D4, D6, D9, D11, D13, D16, D18, D20, D23,D24, D25

Secondary Outcomes

  • Not Applicable(Not Applicable)

Investigators

Sponsor
Btm Ventures Pvt. Ltd.
Sponsor Class
Pharmaceutical industry-Indian

Study Sites (1)

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