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Clinical Trials/CTRI/2025/08/093371
CTRI/2025/08/093371Not yet recruitingUnknown

A Clinical study to Evaluate the efficacy of TomaGlow Brightening Cream for skin Brightening

Fixderma India Pvt Ltd1 site in 1 country36 target enrollmentStarted: August 20, 2025Last updated:

Trial Snapshot

Phase
Unknown
Status
Not yet recruiting
Sponsor
Enrollment
36
Locations
1
Primary Endpoint
1. Change in Skin Gloss

Study Overview

Brief Summary

An open label one arm study to check Saftey and tolerability for Skin brightness

Assessment Points:

Skin Gloss by Glossymeter (T0, T30min, Day 14, and Day 28)

Skin Pigmentation by Mexameter Face(Melanin Index) (T0, Day 14, and Day 28)

Skin Hydration by Corneometer (T0, T30min, Day 14, and Day 28)

Dark Spots by Visioface (T0, Day 14, and Day 28)

Skin discoloration by Chromameter as L value in L*a*b space (T0, Day 14, and Day 28)

Skin Barrier by TEWAMETER (T0, Day 14, and Day 28)

Test Duration-28 Days, Volunteers-36

Study Design

Study Type
Observational

Eligibility Criteria

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

Inclusion Criteria

  • 1.Gender Male and Female 30 Female and 6 males.
  • 2.Subject having dull or dehydrated skin with pigmentation 3.Non-pregnant, non-lactating female.
  • 4.Age between 18 to
  • 5.Subject willing to give written informed consent 6.Women of child bearing potential must have a negative urine pregnancy test 7.Free of any systemic and dermatologic disorder, which in the opinion of the investigator, will interface with the study results or increase the risk of AE.
  • 8.Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of the study.

Exclusion Criteria

  • 1.Subjects who are pregnant, breast feeding, or planning to become pregnant during the study 2.Volunteers with skin conditions such as eczema, psoriasis, etc 3.Have any evidence of systematic cancer, squamous cell carcinoma, basal cell carcinoma in the last 5 years, or any other confounding skin condition.
  • 4.Have open sore or open lesions in the treatment area.
  • 5.Have any condition that, in the opinion of the investigator, would confound the safety and efficacy assessments of the product.
  • 6.Have participated in any interventional clinical trial in the previous 30 days.
  • 7.Have a known sensitivity to any of the constituents of the test product including sensitivities to any of the constituents.
  • 8.Have used, are using, or are planning to use immunosuppressive or immunomodulatory medications (i.e., biologics), including corticosteroids.
  • 9.Have a history of alcohol or illegal drug/ substance abuse or suspected alcohol or illegal drug/substance abuse in the past 2 years.

Outcomes

Primary Outcomes

1. Change in Skin Gloss

Time Frame: At Day 0, Day 14, 28 Day

2. Change in Hydration

Time Frame: At Day 0, Day 14, 28 Day

3. Change in Skin Lightness

Time Frame: At Day 0, Day 14, 28 Day

4. Change in Melanin Index

Time Frame: At Day 0, Day 14, 28 Day

5. Change in Smoothness and Skin Even Tone

Time Frame: At Day 0, Day 14, 28 Day

6. Change in Dark Spots

Time Frame: At Day 0, Day 14, 28 Day

7. Change in TEWL

Time Frame: At Day 0, Day 14, 28 Day

Secondary Outcomes

  • Not Applicable(Not Applicable)

Investigators

Sponsor
Fixderma India Pvt Ltd
Sponsor Class
Pharmaceutical industry-Indian
Responsible Party
Principal Investigator
Principal Investigator

Dr Robin Chugh

CCFT Laboratories

Study Sites (1)

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