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Clinical Trials/CTRI/2025/09/095080
CTRI/2025/09/095080Not yet recruitingNot Applicable

Evaluation of the irritation potential of Lip Care Formulations on healthy human subjects having sensitive skin type

G.D. Pharmaceuticals Pvt. Ltd.1 site in 1 country26 target enrollmentStarted: September 23, 2025
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Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
26
Locations
1
Primary Endpoint
Dermatological safety / Irritation potential on skin
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Objective:The objective of this study will be to evaluate the irritation potential on healthy human subjects having sensitive skin of Lip Care Formulations

Kinetics: T0(before patch application), T1 day (0 hour after the patch removal), T2 days (24 hours after the patch removal ), T8 days (T+1 week after 0 hour of patch removal)

Population: 26healthy  subjects (13 males + 13 females) .

The test area is checked for erythema and oedema caused due to the products and compared with positive control

Study Design

Study Type
Interventional
Allocation
Na
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

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

Inclusion Criteria

  • •Healthy Human Subjects 2) Skin should be healthy on the studied anatomic unit 3)Subjects representing sensitive skin type.

Exclusion Criteria

  • •For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
  • •Having refused to give his/her assent by not signing the consent form.
  • •Taking part in another study liable to interfere with this study.
  • •Being diabetic.
  • •Being asthmatic.
  • •Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol).
  • •Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin).
  • •Having undergone a surgery requiring a general anesthesia of more than one hour in the past 6 months.
  • •Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.

Outcomes

Primary Outcomes

Dermatological safety / Irritation potential on skin

Time Frame: Baseline,0 hrs,24 hrs and 7 days

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
G.D. Pharmaceuticals Pvt. Ltd.
Sponsor Class
Pharmaceutical industry-Indian
Responsible Party
Principal Investigator
Principal Investigator

Dr Niharika Salian

MASCOT-SPINCONTROL India Pvt. Ltd.

Study Sites (1)

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