A study of Chewable Gummies for Fine Line/Wrinkles, Hyperpigmentary Spots and Under Eyes Dark Circles.

Completed

Conditions: Subjects with fine line/wrinkles, hyperpigmentary spots and under eyes dark circles will be included in the study.

Registration Number: CTRI/2022/08/045104

Lead Sponsor: Ikaria Wellness Pvt Ltd

Brief Summary: This is an openlabel, single arm, clinical study to evaluate efficacy and safety of chewablegummies in healthy adult subjects with fine line/wrinkles, hyperpigmentaryspots and under eyes dark circles.

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

Study will consist of total 05 visits.

Visit 01: Screening Visit (Within 30 days prior to Day01)

Visit 02: Enrollment Visit (Day 01)

Visit 03: Evaluation Phase (Day 25 Â± 02 Days)

Visit 04: Evaluation Phase (Day 50 Â± 02 Days)

Visit 05: Evaluation Phase and End of Study (Day 75 Â± 02 Days)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 36

Inclusion Criteria

1.Subject has a fine line/wrinkles score of â€œ2â€ (Few number of discreet fine lines) or greater surrounding the crowâ€™s feet area as per Physician Global Assessment (PGA).
2.Subject has at least 2 hyperpigmentary spots on the face.
3.Subjects with Grade 2 and Grade 3 under eyes dark circles as determined by 6-point grading scale.

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 with any pigmentary disorder including Freckles and melasma.
3.Subject having excessive hair, moles, open wounds, cuts, abrasions, irritation symptoms, tattoos, scars, sunburn or any dermatological condition on the test site(s) that can interfere with the reading.
4.Subjects who are receiving topical or systemic treatments.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of fine line/wrinkles, skin dryness, coarse wrinkling/lines, laxity by Physician Global Assessment (PGA) using Griffiths Scale by Dermatologist	Day 01 (before application), Day 25 (plus minus 02 Days), Day 50 (plus minus 02 Days) and Day 75 (plus minus 02 Days).

Secondary Outcome Measures

Name	Time	Method
Assessment of Fine wrinkling, Coarse wrinkling, laxity using Severity Scoring by Dermatologist	Day 01 (before application), Day 25 (plus minus 02 Days), Day 50 (plus minus 02 Days) and Day 75 (plus minus 02 Days)
Assessment of skin pigment using 9-point scale by Dermatologist	Day 01 (before application), Day 25 (plus minus 02 Days), Day 50 (plus minus 02 Days) and Day 75 (plus minus 02 Days).
Assessment of under-eyes dark circles using 6-point grading scale by Dermatologist	Day 01 (before application), Day 25 (plus minus 02 Days), Day 50 (plus minus 02 Days) and Day 75 (plus minus 02 Days).
Assessment of uneven skin tone using Felix Von Luschan Skin colour chart	Day 01 (before application), Day 25 (plus minus 02 Days), Day 50 (plus minus 02 Days) and Day 75 (plus minus 02 Days).
Assessment of Skin radiance using Modified Griffiths Scale by Dermatologist	Day 01 (before application), Day 25 (plus minus 02 Days), Day 50 (plus minus 02 Days) and Day 75 (plus minus 02 Days).
Assessment of skin pigmentation using MexameterÂ® MX 18	Day 01 (before application), Day 25 (plus minus 02 Days), Day 50 (plus minus 02 Days) and Day 75 (plus minus 02 Days).
Assessment of Skin Moisturization using CorneometerÂ® CM 825 / MoistureMeterSC	Day 01 (before application), Day 25 (plus minus 02 Days), Day 50 (plus minus 02 Days) and Day 75 (plus minus 02 Days).
Assessment of Skin gloss using Skin-Glossymeter GL 200	Day 01 (before application), Day 25 (plus minus 02 Days), Day 50 (plus minus 02 Days) and Day 75 (plus minus 02 Days).
Assessment of Skin firmness using Cutometer dual MPA 580	Day 01 (before application), Day 25 (plus minus 02 Days), Day 50 (plus minus 02 Days) and Day 75 (plus minus 02 Days).
Assessment of wrinkles of crowâ€™s feet area, pigmentation, skin texture and under-eyes dark circles using 3D analysis system	Day 01 (before application), Day 25 (plus minus 02 Days), Day 50 (plus minus 02 Days) and Day 75 (plus minus 02 Days).
Subject Satisfaction Questionnaire	Day 25 (plus minus 02 Days), Day 50 (plus minus 02 Days) and Day 75 (plus minus 02 Days).
Product Response Index (Perception about Product)	Day 25 (plus minus 02 Days), Day 50 (plus minus 02 Days) and Day 75 (plus minus 02 Days).

Trial Locations

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