None listed
Conditions
Interventions
Intervention1: Test IP. (Oral tablets (TonEQ Tablets): one Tablet need to be consumed twice daily after meals for 12 weeks.
Control Intervention1: Placebo Tablets: one tablet needs to be consumed twic
Sponsors
Transformative Learning Solutions Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Female adult subjects in general good health as determined from a re-cent medical history, general physical examination, dermatological as-sessment. 2.Subjects in the age group of 40-60 years (both ages inclusive). • Subject with Fitzpatrick skin types III to V 3.Each subject should have hyperpigmentary regions (may or at least one spot of 3mm size) 4. Subject free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face. 5.Subject who agrees not to use any other product/treatment/home remedy/ except the provided products on their face during the study period other than the test product. 6.Subjects who agree not to carry out bleaching or any other procedures in-cluding facial etc. on face during the study period. 7.Subjects who agree not to expose to excessive sun light. (Sun exposure not more than half an hour daily and during that time use of umbrella to cover face). 8.Subjects willing to give a voluntary written informed consent, photog-raphy release and agree to come for regular follow-up. 9.Subjects willing to abide by and comply with the study protocol.
Exclusion criteria
Exclusion criteria: 1. Subject with any other signs of significant local irritation or skin disease. 2.Subject currently taking any medication, which the Investigator believes may influence the interpretation of the data. 3.Subject having clinically significant systemic or cutaneous disease, chronic illness or had major surgery in the last year. 4.Subjects who do not agree to remove all jewelry on/around face (e.g., necklace, earrings, if possible, nose ring), during Digital imaging. 5.Subjects having hair style which covers almost the entire forehead 6.Subjects undergoing any treatment of any skin condition on their face/forearm. • Subjects not willing to discontinue other topical facial products. 7.Subject allergic or sensitive to bar cleansing products, cosmetics, creams/lotions, artificial jewellery or anything else. 8.Pregnant women (as confirmed by UPT) and lactating women 9.Subjects on any medical treatment either systemic/topical in the past 1 month or currently taking medication including food supplements.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1.To evaluate improvement in epidermal turnover rate using desquamation technique.Timepoint: Week 1, 4 ,8 & 12 | — |
Primary
| Measure | Time frame |
|---|---|
| •To evaluate the following parameters by Dermatological Visual Assessment using MSCR Glow & Radiance Composite Scale: a.Skin Glow b.Skin Clarity (Patchiness) c.Even Tone •To evaluate Photoaging by Dermatological Visual Assessment using Homogenecity of Age-spots /Hyperpigmentation Scale. •To evaluate hyperpigmentation using Global Hyperpigmentation Scale. Timepoint: Week 1, 4 ,8 & 12 | — |
Countries
India
Contacts
Public ContactSatyendra Kumar
MS Clinical Research Pvt Ltd
Outcome results
None listed