MedPath

Anti-Pigmentation activity of Vitamin-C Moisturizer

Not Applicable
Not yet recruiting
Conditions
Not Applicable
Registration Number
CTRI/2025/05/086633
Lead Sponsor
Pureplay Skin Science Pvt Ltd
Brief Summary

A single blind one arm study.

Each participant entering the trial will be assigned to a regimen ofinvestigational product.



Day 0 (T0) - Baseline Measurements:

1. Skin Gloss (Glossymeter): (0, 14, 28 days)

2. Skin Hydration (Corneometer): (T0, 30min, 14, 28 days)

3. TEWL (Tewameter): (0, 14, 28 days)

4. Skin Pigmentation (Melanin Index) (Mexameter): (0, 14, 28 days)

5. Dark Spots (Visioface): (0, 14, 28 days)

6. Skin Color (Chromameter): (0, 14, 28 days)

7. HD Imaging with DSLR: (0, 28 days)

8. Visioscan Imaging: (0, 28 days)



Dedicated Questionnaire (CRF)

1. Light weight

2. Quick Absorbing

3. Non-Irritant

4. Non-Sticky

5. Non-Greasy

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
Not specified
Target Recruitment
36
Inclusion Criteria
  • Gender: Non-pregnant, non-lactating female aged between18 to 50.
  • Subject with Pigmentation.
  • Subject willing to give written informed consent 4.
  • Women of child bearing potential must have a negative urine pregnancy test 5.
  • 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.
  • Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of the study.
Exclusion Criteria
  • 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.
  • 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.
  • Have participated in any interventional clinical trial in the previous 30 days.
  • Have a known sensitivity to any of the constituents of the test product including sensitivities to any of the constituents.
  • Have used, are using, or are planning to use immunosuppressive or immunomodulatory medications (i.e., biologics), including corticosteroids.
  • Have a history of alcohol or illegal drug/ substance abuse or suspected alcohol or illegal drug/substance abuse in the past 2 years.

Study & Design

Study Type
PMS
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
2. Change in Wrinkle countAt T0, T14 and T28Days
4. Change in Melanin IndexAt T0, T14 and T28Days
1. Change in Dark spots & PigmentationAt T0, T14 and T28Days
3. Change in skin glossAt T0, T14 and T28Days
5. Change in skin lightnessAt T0, T14 and T28Days
6. Change in skin Hydration and TEWLAt T0, T14 and T28Days
Secondary Outcome Measures
NameTimeMethod
Not ApplicableNot Applicable

Trial Locations

Locations (1)

CCFT laboratories

🇮🇳

Meerut, UTTAR PRADESH, India

CCFT laboratories
🇮🇳Meerut, UTTAR PRADESH, India
Dr Robin Chugh
Principal investigator
9027285265
robinderm25@gmail.com

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