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A study to evaluate the Safety and Efficacy of 1 test product in reducing dark spots on the face.

A clinical study to evaluate Safety, In-Use Tolerability and Efficacy of HTSS-052203 in reducing the facial dark spots in Healthy Adult Subjects.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050575
Enrollment
48
Registered
2023-03-10
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

None listed

Interventions

Intervention1: HTSS-052203: 3 to 5 drops of test product to be applied on face and massage gently until it gets absorbed. To be used once a day. Control Intervention1: None: None

Sponsors

Himalaya Wellness Company
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Subject has at least 2 dark spots on the face (suntan, blemishes, sunspots and age-spots). Preferably equal number of subjects will be recruited in all indications. 2) Subjects with mild to moderate dark spots as per Investigator global assessment (IGA). 3) Subjects with oily skin having Sebumeter measurement > 180 (μg/cm2).

Exclusion criteria

Exclusion criteria: 1) Subjects having any active dermatological skin diseases (e.g., psoriasis, atopic dermatitis, rosacea etc.), that might interfere with clinical assessments. 2) Subjects who are receiving topical or systemic treatments / undergoing skin lightening treatment. 3) Subjects receiving medications (e.g., steroids or antihistamines) which would compromise the study. 4) Subjects with chronic illness which may influence the cutaneous state. 5) Subjects having history of diabetes, acute cardiac and circulatory diseases, HIV, hepatitis. 6) Subjects using other marketed anti-acne/anti-aging/skin lightening products during the study period or in the past 6 weeks.

Design outcomes

Primary

MeasureTime frame
1) Assessment of dark spots using Investigator global assessment (IGA). 2) Assessment of skin pigment using 9-point scale. 3) Assessment of dark spots using Mexameter. 4) Assessment of skin sebum level using SebumeterTimepoint: Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 282) Assessment of skin pigment using 9-point scale. 3) Assessment of dark spots using Mexameter. 4) Assessment of skin sebum level using Sebumeter

Secondary

MeasureTime frame
Assessment of Skin gloss using Skin-GlossymeterTimepoint: Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 28;Assessment of Skin Moisturization using Corneometer / MoistureMeterSCTimepoint: Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 28;Assessment of Skin radiance using Modified Griffiths ScaleTimepoint: Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 28;Assessment of Subject Satisfaction Questionnaire after product usageTimepoint: Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 28;Assessment of the colour of dark spot using ChromameterTimepoint: Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 28;Assessment of uneven skin tone using Felix Von Luschan Skin colour chartTimepoint: Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 28;Assessment of skin elasticity using CutometerTimepoint: Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 28;Assessment of dark spots and skin texture (roughness) using 3D analysis systemTimepoint: Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 28;Assessment of Product Response Index (Perception about Product) after product usageTimepoint: Day 28;Assessment of skin barrier function by measuring Transepidermal Water Loss (TEWL) using TEWAmeter / VapometerTimepoint: Day 01 (before application & after application), Day 07, Day 14, Day 21 and Day 28

Countries

India

Contacts

Public ContactDr Simran Sethi

Cliantha Research

pjoshi@cliantha.com8000085049

Outcome results

None listed

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