Health Condition 1: L709- Acne, unspecified
Conditions
Interventions
Intervention1: LUMISILVR Gel: Mode of Usage- Apply a thin layer of the test product topically to the affected areas of clean, dry skin. Gently spread without rubbing vigorously and allow it to absorb
Sponsors
Viridis Biopharma Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 16 to 30 years at the time of consent. 2) Sex: Males and non-pregnant or non-lactating females. 3) Females of childbearing potential must have a self-reported negative pregnancy test. 4) Participants are generally in good health. 5) Participants with mild to moderate acne, acne marks, facial blemishes, and oily, combination, dry, or sensitive facial skin will be enrolled in the study. Participants will be distributed almost equally among the four skin-type categories. 6) Patients with acne of mild to moderate severity as per the IGA scale. 7) participants who commit not to use medicated skincare products (OTC products, cosmetic- comedogenic products, moisturizing products, anti-acne and anti-seborrhoeic products) other than the test product for the entire duration of the study. 8) Participants are not allowed to participate in any other study until this study is complete. 9) Having childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device or injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation. 10) Participants or participant s legal parent or legal guardian willing to give written informed consent or parental informed consent or assent form. 11) Participants must agree to record each use of the test product in the participant s diary card on daily basis.
Exclusion criteria
Exclusion criteria: 1) History of any dermatological condition of the skin disease within last 3 months. 2) Participants with present condition of allergic response to any cosmetic product. 3) Participants under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines, corticosteroid therapy etc.) that might influence the outcome of the study. 4) Participants had performed any acne treatment throughout the study. 5) Participants who have applied topical product for at least 4 weeks and any systemic product for at least 3 months, adjuvant product/therapy before they participated in the study. 6) History of alcohol or drug addiction. 7) Any other condition which could warrant exclusion from the study, as per the dermatologist s/investigator s discretion. 8) Pregnant or breastfeeding or planning to become pregnant during the study period. 9) History of chronic illness which may influence the cutaneous state. 10) Participants participating in other similar cosmetics, devices or therapeutic studies or skincare products within the last four weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate the effectiveness of the test product in terms of change in total acne lesions from baseline before usage of the test product and after usage of the test product. 2. To evaluate the effectiveness of the test product in terms of change in Non-inflammatory acne lesion count (sum of open and closed comedones) from baseline before usage of the test product and after usage of the test product. 3. To evaluate the effectiveness of the test product in terms of change in Inflammatory acne lesion count (sum of papules and pustules) from baseline before usage of the test product and after usage of the test product. 4. To evaluate the effectiveness of the test product in terms of change in change in acne severity from baseline before usage of the test product and after usage of the test product. 5. To evaluate the effectiveness of the test product in terms of porphyrin size quantity and value from baseline before and after usage of test product.Timepoint: 20 min, Day 07, Day 14 and Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of the test product in terms of change in Sebum Level from baseline before usage of the test product and after usage of the test product.Timepoint: 20 min, Day 07, Day 14 and Day 28 ;To evaluate the effectiveness of the test product in terms of change in skin melanin and erythema from baseline before usage of the test product and after usage of the test product.Timepoint: 20 min, Day 07, Day 14 and Day 28;To evaluate the effectiveness of the test product in terms of change in skin hydration from baseline before usage of the test product and after usage of the test product.Timepoint: 20 min, Day 07, Day 14 and Day 28;To evaluate the effectiveness of the test product in terms of change in overall tone of the skin by L, a, b, ITA from baseline before usage of the test product and after usage of the test productTimepoint: 20 min, Day 07, Day 14 and Day 28;To evaluate the effectiveness of the test product in terms of change in skin barrier function from baseline before usage of the test product and after usage of the test product.Timepoint: 20 min, Day 07, Day 14 and Day 28 ;To evaluate the effectiveness of the test product in terms of change in visual appearance of face from baseline before usage of the test product and after usage of the test product.Timepoint: 20 min, Day 07, Day 14 and Day 28 ;Safety will be determined by local skin tolerance such as skin itching, burning, scaliness and erythema from baseline before usage of the test product and after usage of the test product. (safety outcome)Timepoint: 20 min, Day 07, Day 14 and Day 28;To evaluate the effectiveness of the test product in terms of change in change in Product perception questionnaire from baseline before usage of the test product and after usage of the test product.Timepoint: 20 min, Day 07, Day 14 and Day 28 | — |
Countries
India
Contacts
Public ContactDr Maheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed