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Clinical Trials/CTRI/2024/09/073196
CTRI/2024/09/073196CompletedPost Marketing Surveillance

A Clinical Study to Evaluate the 48-hours Moisturization Potential of Dermavive Multiple skin Care Formulations on Healthy Human Subjects

UAS Pharmaceuticals Pty Ltd.1 site in 1 country32 target enrollmentStarted: September 10, 2024Last updated:
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Trial Snapshot

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

Study Overview

Brief Summary

Test Product-

1. Dermavive Moisturising Lotion

  1. Dermavive Body Hydrator

  2. Dermavive dry Skin Creme

  3. Dermavive Hydra Cleanser

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

Study Design

Study Type
Pms
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 45.00 Year(s) (—)

Inclusion Criteria

  • •1.Gender: Male or Female with age 18-45, with male:female (50:50) ratio with normal , oily (avoid acne and too much oily skin) and combination skin.
  • •3 to 4 candidates with Sensitive skin.
  • •Subjects willing to give written informed consent
  • •Women of child bearing potential must have a negative urine pregnancy test prior to study entry.
  • •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 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 hydration

Time Frame: At T+0min, T+30min, T+2hrs, T+8hrs, T+24hrs, T+48hrs

Secondary Outcomes

  • Not Applicable(Not Applicable)

Investigators

Sponsor
UAS Pharmaceuticals Pty Ltd.
Sponsor Class
Pharmaceutical industry-Global
Responsible Party
Principal Investigator
Principal Investigator

Dr Robin Chugh

CCFT Laboratories

Study Sites (1)

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