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Clinical Trials/CTRI/2023/10/059057
CTRI/2023/10/059057RecruitingNot Applicable

A Clinical Study to evaluate the skin irritation potential of Plum multiple skin care products on healthy human subjects.

Pureplay Skin Sciences (I) PVT LTD.1 site in 1 country24 target enrollmentStarted: October 30, 2023Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
24
Locations
1
Primary Endpoint
Change in Skin Irritation Score-erythema & oedema
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The below products would be tested as per the guideline IS4011 for dermal safety assessme****nt.

  1. Plum Rice Water & Niacinamide Clear Moisture Gel 2 %

  2. Plum 1% Oat & Allantoin all-day nourishing Cream

  3. Plum Alpha Arbutin & Hyaluronic Acid Face Serum 2%

  4. Plum Rice Water and Niacinamide Serum 10%

The product will be tested for skin irritation on 24 human volunteers.

Assessment would be done on day 0, day 1, with followup visit on day 8 for erythema and Oedema scoring.

Study is done as per BIS standard 4011

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/women between 18 and 65 years.
  • •Photo type 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/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/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: Day 0, Day 2, Day 8

Secondary Outcomes

  • Not Applicable(Not Applicable)

Investigators

Sponsor
Pureplay Skin Sciences (I) PVT LTD.
Sponsor Class
Pharmaceutical industry-Indian

Study Sites (1)

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