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Clinical study to evaluate the safety and efficacy of a cream in reducing skin pigmentation in healthy pregnant females and lactating females with Mild to Moderate Melasma.

An open-label, single-arm study to evaluate efficacy and safety of a cream in reducing skin pigmentation in healthy pregnant female (1st and 2nd trimester) and lactating female (post pregnancy mother having 0 month to 18 months old baby) subjects with Mild to Moderate Melasma.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/044646
Enrollment
60
Registered
2022-08-04
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

Health Condition 1: L989- Disorder of the skin and subcutaneous tissue, unspecified

Interventions

Intervention1: Melasma Cream: Approx. 2 gm of test product to be applied on affected area. Twice a day application for a period of 140 days. Control Intervention1: Not Applicable: Not Applicable

Sponsors

Zydus Wellness Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Sex: Females, either of the following a. Healthy pregnant females (1st and 2nd trimester â?? preferably first half of the 2nd trimester). b. Post-pregnant females (post pregnancy mother having 0 month to 18 months old baby) at the time of consent. 2) Subjects with mild to moderate melasma determined by Melasma Area and Severity Index (MASI) score. 3) Subjects having at least 2 hyperpigmentary spots on the face. 4) Atleast 10 subjects with hypopigmentation along with melasma and at least 2 hyperpigmentary spots on the face. 5) Subjects who have a history of delivery within 42 weeks (applicable for post-pregnant females only).

Exclusion criteria

Exclusion criteria: 1) Subjects who have pigmentation due to any other reason than exposure to UV light like result of hormonal changes, freckles. 2) Subjects with skin disease (e.g., moderate to severe acne vulgaris face or nodulocystic acne, psoriasis, atopic dermatitis or any other condition as per Investigators discretion), which would interfere with the assessment area. 3) Subjects having history of diabetes, acute cardiac and circulatory diseases, HIV, hepatitis. 4) Participation in a similar clinical study within the previous 90 days.

Design outcomes

Primary

MeasureTime frame
1)Dermatological evaluation of the severity of melasma using Melasma Area and Severity Index (MASI) Score 2)Evaluation of skin hyperpigmentation using Mexameter Timepoint: Baseline, Week 4, Week 12, Week 20—

Secondary

MeasureTime frame
Dermatological evaluation of skin radiance using modified Griffiths Scale.Timepoint: Baseline, Week 4, Week 12, Week 20;Evaluation of dark spot /blemishes /hypopigmentary spots using Chromameter.Timepoint: Baseline, Week 4, Week 12, Week 20;Evaluation of skin pigmentation /melasma /hypopigmentation by image analysis.Timepoint: Baseline, Week 4, Week 12, Week 20;Evaluation of uneven skin tone using Felix Von Luschan Skin colour chart.Timepoint: Baseline, Week 4, Week 12, Week 20;Photographs by VISIA CRTimepoint: Baseline, Week 4, Week 12, Week 20;Subject Satisfaction Questionnaire and Product Response Index (Perception about Product).Timepoint: Baseline, Week 4, Week 12, Week 20—

Countries

India

Contacts

Public ContactDr Simran Sethi

Cliantha Research

pjoshi@ofacto.com8000085049

Outcome results

None listed

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