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Clinical Trials/CTRI/2024/12/078451
CTRI/2024/12/078451SuspendedPost Marketing Surveillance

A Clinical Study to Evaluate the 48-hours Moisturization Potential of Piramal Lacto calamine Retinol Gel on Healthy Human Subjects

Piramal Pharma Limited1 site in 1 country32 target enrollmentStarted: December 30, 2024Last updated:
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Trial Snapshot

Phase
Post Marketing Surveillance
Status
Suspended
Enrollment
32
Locations
1
Primary Endpoint
Change in hydration
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Test Product:

Piramal Lacto Calamine Retinol Gel

Dose: Gently massage approx. 1 drop of over one block as assigned (forearm) Route of Administration: Topical Duration: 48 hour

Study Design

Study Type
Pms
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 50.00 Year(s) (—)

Inclusion Criteria

  • •1.Gender: Male or Female with age 18-
  • •Subjects willing to give written informed consent 3.Women of child bearing potential must have a negative urine pregnancy test prior to study entry.
  • •4.Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events
  • •Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of the study.

Exclusion Criteria

  • •Pregnant or nursing mothers
  • •Subject with oily skin or with too much Sweating
  • •Have open sores or open lesions in the treatment area(s)..
  • •4.Scars, excessive terminal hair or tattoo on the studied area 5.Henna tattoo anywhere on the body (in case of studies involving hair dyes) 6.Dermatological infection or pathology on the level of studied area 7.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye) 8.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures 9.Chronic illness which may influence the outcome of the study 10.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) 11.Have a known sensitivity to any of the constituents of the test product 12.Have not skin related issues.

Outcomes

Primary Outcomes

Change in hydration

Time Frame: T0min,T30min, T2hrs, T8hrs, T+24hrs, T+ 48hours

Secondary Outcomes

  • Change in TEWL(T0min, T30min, T24hrs, T48hrs)

Investigators

Sponsor Class
Pharmaceutical industry-Indian
Responsible Party
Principal Investigator
Principal Investigator

Dr Robin Chugh

CCFT Laboratories

Study Sites (1)

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