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.

Completed

Brief Summary: The potentialsubjects will be screened as per the inclusion and exclusion criteria onlyafter obtaining written informed consent from the subjects.

There are total 5 visits in the study i.e.

Â·        Visit 01: Screening Visit (within 30 days prior to day01)

Â·        Visit 02: Enrolment (Week 1, Day 01)

Â·        Visit 03: Evaluation phase (Week 4, Day 28 Â± 2 days)

Â·        Visit 04: Evaluation phase (Week 12, Day 84 Â± 2 days)

Â·        Visit 05: Evaluation phase and End of the study (Week20, Day 140 Â± 2 days)

Beforeentering the facility, at security check-post, subjects will be asked forpre-entry scrutiny check for COVID-19 symptoms. Study can be conducted inmultiple batches (set of subjects) in order to follow the norms of covid-19restrictions.

Instrumentalassessment, dermatological assessments and questionnaires will be assessed.Photographs will be taken using VISIA-CR. Images will be analyzed using ImagePro Software/3D analysis system. Safety will be assessed throughout the studyby monitoring of adverse events.

Recruitment & Eligibility

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

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.

Primary Outcome Measures

Name	Time	Method
1)Dermatological evaluation of the severity of melasma using Melasma Area and Severity Index (MASI) Score	Baseline, Week 4, Week 12, Week 20
2)Evaluation of skin hyperpigmentation using Mexameter	Baseline, Week 4, Week 12, Week 20

Secondary Outcome Measures

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

Locations (1): Cliantha Research
🇮🇳
Ahmadabad, GUJARAT, India
Cliantha Research
🇮🇳Ahmadabad, GUJARAT, India
Dr Parth Joshi
Principal investigator
8000085049
pjoshi@ofacto.com