Skip to content

Safety and Efficacy assessment of product in reducing Skin Tan and enhancing skin brightening on Indian volunteers.

Evaluation of the in vivo safety and efficacy of cosmetic formulations in conferring tan reduction and skin lightening or brightening benefits on Indian Volunteers. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/085211
Enrollment
35
Registered
2025-04-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Sunscreen Cream: Product to be applied on Face and Forearms twice daily when indoors and every 40m on face and Sun exposed body parts when exposed to Sun. Frequency: Twice daily when

Sponsors

ITC LIMITED
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Healthy subjects 2.Skin that is healthy on the studied anatomic unit 3.Subjects with visible skin Tan on face and dorsal forearm, at least 1 shade darker than the Sun protected upper volar arm as per MASCOT s Indian skin shade card. 4.Subjects with a Chromameter L value in the range of 40 to 60 on cheeks, and L value on volar upper arm of at least 2 units higher than the L value on forehead and dorsal forearm. 5.Atleast 20 Subjects with few dark spots (other than melasma or chloasma or rosacea or birth mark or moles or warts or chronic pigmentation) on face. 6.Volunteer who exhibit good tolerance to the investigational product with no signs of sensitivity. 7.Having Varied skin types 8.Subjects willing to abide by the study protocol, laid restrictions and consenting to visit the site for periodic assessments on the scheduled dates.

Exclusion criteria

Exclusion criteria: 1)Subjects who have started, changed or stopped a hormonal treatment (hormonal contraception, Hormonal Replacement Therapy, thyroid ) in the past 3 months 2)Subjects who have taken an oral retinoid-based treatment in the past 6 months. 3)Subjects having had a local retinoid-based treatment on the studied areas in the previous month. 4)Subject having had beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask) in the previous week. 5)Subjects having practiced water activities (swimming pool, sauna, hammam) in the previous week 6)Subjets having drunk or eaten caffeine based products (coffee, cola, tea, ), alcohol, highly spiced food or smoked in the two hours preceding the measurements. 7)Subject having practiced sport the day of start of the study. 8)subjects who are either pregnant or nursing. 9)Subjects who have participated in similar kind of investigation

Design outcomes

Primary

MeasureTime frame
1)Reduction in skin tan and related hyperpigmentation (Dark spots or blotches or patches, uneven tone). 2)Improvement in skin Lightening, Brightness or Radiance.Timepoint: Baseline, Post 1 product application, Post 24 hours after 1st product application, Day 14, Day 21 and Day 28

Secondary

MeasureTime frame
Improvement in skin parameters like Color or complexion, Even tone, Hydration or Moisturization, Clarity, Texture, Softness or Suppleness, Skin brightness or Radiance or Glow, Smoothness compared to baseline as per Dermatologist s assessment, Subjects self-assessment or Instrumental measurementsTimepoint: Baseline, Post 1 product application, Post 24 hours after 1st product application, Day 14, Day 21 and Day 28

Countries

India

Contacts

Public ContactDr Mohit Lalvani

MASCOT-SPINCONTROL India Pvt. Ltd.

poojayadav@mascotspincontrol.in02243349191

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026