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Clinical Trials/CTRI/2025/03/082343
CTRI/2025/03/082343Not yet recruitingPost Marketing Surveillance

A clinical study to evaluate the 72-hours Moisturization potential of Galaxy (SA-CS-GD-1 and SA-CS-B-1) on healthy human volunteers

Galaxy Surfactants Limited1 site in 1 country32 target enrollmentStarted: March 19, 2025Last updated:
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Trial Snapshot

Phase
Post Marketing Surveillance
Status
Not yet recruiting
Sponsor
Enrollment
32
Locations
1
Primary Endpoint
Change in hydration
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Test Product:

1. SA-CS-GD-1 (Cream with active)

2. SA-CS-B-1 (Base Cream)

Dose: Gently massage approx. 1 drop of over one block as assigned (forearm) Route of Administration: Topical Duration: 72 hours

Study Design

Study Type
Pms
Allocation
Not Applicable
Masking
Open Label

Eligibility Criteria

Ages
18.00 Year(s) to 40.00 Year(s) (—)

Inclusion Criteria

  • •Gender: Male or Female 18 to 40
  • •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).

Exclusion Criteria

  • •Subjects who are pregnant, breast-feeding, or planning to become pregnant during the study.
  • •Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last years, or any other confounding skin condition.
  • •Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments of the product.
  • •Have participated in any interventional clinical trial in the previous 90 days.
  • •Have a known sensitivity to any of the constituents of the test product
  • •Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including corticosteroids.

Outcomes

Primary Outcomes

Change in hydration

Time Frame: T0min, T30min, T+2hrs, T+8hrs, T+24hrs, T+ 48hours, T+72hrs

Secondary Outcomes

  • Change in TEWL(t0min, t30min, t24hrs, t48hrs, t72hrs)

Investigators

Sponsor
Galaxy Surfactants Limited
Sponsor Class
Pharmaceutical industry-Indian

Study Sites (1)

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