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Clinical Trials/CTRI/2025/09/094638
CTRI/2025/09/094638
Not yet recruiting
Post Marketing Surveillance

An open-label clinical study to check the efficacy of 1% Hyaluronic Sunscreen Aqua Gel on hydration, plumper-looking skin, and reduction in skin dryness in healthy volunteers

THE DERMA CO.1 site in 1 country36 target enrollmentStarted: September 23, 2025Last updated:
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Overview

Phase
Post Marketing Surveillance
Status
Not yet recruiting
Sponsor
THE DERMA CO.
Enrollment
36
Locations
1
Primary Endpoint
1. change in skin hydration
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

An Open Label clinical study within subject pre-post application Assessments

Test Area- face,  No of volunteers- 36

Age- 18-55years

Assessments:

  1. Corneometer- for hydration

  2. DSLR imaging- full face and closer with plumer skin imaging

  3. Clinical and visual assessments

  4. Dermatologist visual grading 0-3 scale

  5. Subjective and Sensory Assessments

  6. Immediate sensory Questionnaire

Dose and application- Adequate amount applied uniformly on face

Time Points:  0min, 30min, 2hrs and 8hrs

Study Design

Study Type
Pms
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 55.00 Year(s) (—)

Inclusion Criteria

  • •Gender: Non-pregnant, non-lactating female Age 18–55 years.
  • •Subject willing to give written informed consent
  • •Women of child bearing potential must have a negative urine pregnancy test
  • •Fitzpatrick skin type II–V.
  • •Healthy skin on test areas.
  • •Agree to avoid other facial actives 7 days prior to visit.

Exclusion Criteria

  • •Subjects who are pregnant, breast feeding, or planning to become pregnant during the study
  • •Have any evidence of systematic cancer, squamous cell carcinoma, basal cell carcinoma in the last 5 years, or any other confounding skin condition.
  • •Have open sore or open lesions in the treatment area
  • •Have any condition that, in the opinion of the investigator, would confound the safety and efficacy assessments of the product.
  • •Have participated in any interventional clinical trial in the previous 30 days.
  • •Known allergy to product ingredients.
  • •Active dermatitis, wounds or lesions on test areas.
  • •Facial procedures in prior 4 weeks (e.g., peels, lasers).

Outcomes

Primary Outcomes

1. change in skin hydration

Time Frame: At T0, 30 minutes, 2 hour and 8 hours

2. DSLR Imaging

Time Frame: At T0, 30 minutes, 2 hour and 8 hours

3. Dermatologist visual grading

Time Frame: At T0, 30 minutes, 2 hour and 8 hours

Secondary Outcomes

  • 1. SGA(At T0, 30 minutes, 2 hour and 8 hours)

Investigators

Sponsor
THE DERMA CO.
Sponsor Class
Pharmaceutical industry-Indian
Responsible Party
Principal Investigator
Principal Investigator

Dr Robin chugh

CCFT Laboratories

Study Sites (1)

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