None listed
Conditions
Interventions
Intervention1: Multiple purpose restorative cosmetic formulation: Onguent-23116.97
Name reference, nature: Test Product: Multiple purpose restorative ointment
Onguent - 23116.97
Investigational a
Sponsors
ADAM Laboratoires
Eligibility
Inclusion criteria
Inclusion criteria: 1 Healthy Indian male or female adult participants aged 18 to 65 years both inclusive and pediatric participants aged 06 to 12 years with at least 20 percent pediatric population 2 Participants with skin phototypes three to six according to the Fitzpatrick classification 3 Participants presenting with at least one visible scar over the body or face after burn trauma surgery laser or cuts with at least 50 percent after the inflammation stage is over 4 Participants with localized dryness or irritated skin on multiple body parts such as face arms and legs with at least 50 percent including some participants with fissures cracks or very dry skin especially on feet or legs 5 Participants with sensitive skin confirmed by stinging test at screening visit with at least 50 percent 6 Participants with diagnosed diabetes type one or type two for at least 6 months as self declared at screening visit with at least 50 percent 7 Participants with no other medical history or active systemic or skin disease 8 Participants who agree not to undergo UV therapy sun tanning sunbathing or any aesthetic procedures during the study 9 Participants who agree to use only the test product and avoid other topical products on the study areas 10 Participants willing and able to follow the study schedule and requirements 11 Participants willing to provide written informed consent and able to read write and understand Hindi or English 12 Female participants of childbearing potential who agree to undergo urine pregnancy testing
Exclusion criteria
Exclusion criteria: 1 Pregnant or lactating women or women planning pregnancy during the study period as self declared at screening and confirmed by urine pregnancy test at day zero 2 Participants with diabetes showing reduced sensitivity less than seven out of ten during monofilament test over soles at screening 3 Participants who have started stopped or changed hormonal treatment such as contraceptive pills within the past one month 4 Participants with known history of allergy or hypersensitivity to any topical cosmetic or test product ingredients 5 Participants with significant comorbidities oozing skin lesions ulcers active skin infections or any condition that may affect safety or study results 6 Participants using systemic or topical medications such as corticosteroids antibiotics retinoids anti inflammatory drugs or supplements that may interfere with the study within four weeks before or during the study 7 Participants who have undergone recent dermatological procedures such as laser therapy dermabrasion or injections in target areas within four weeks before the study or planned during the study 8 Participants who have recently sunbathed used tanning methods undergone phototherapy or plan to do so during the study 9 Participants involved in another clinical study within fourteen days before screening or currently participating in another trial 10 Participants unable to follow study instructions or cannot be contacted in case of emergency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective 1 To evaluate the efficacy and tolerability of the test product in improving skin hydration barrier repair skin soothing and scar appearance over 4 to 8 weeks 2 To assess skin dryness using ODS Overall Dry Skin score and SRRC symptom score at defined timepoints 3 To evaluate scar appearance using POSAS at D0 D28 and D56 4 To assess skin hydration using Corneometer and transepidermal water loss using Tewameter 5 To evaluate skin and scar characteristics including roughness redness height width texture and volume using Antera 3D imagingTimepoint: Visit 1 Screening D 7 to D 1 Visit 2 Baseline Visit 2 D0 and D0 Time Visit 3 Telephonic visit D14 Visit 4 Evaluation D28 plus minus 2 days End of study for non scar panel Visit 5 End of study visit D56 plus minus 2 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Global photography using DSLR camera showing skin dryness for illustrative purposes at D0 and D28 2 Self assessment questionnaires SAQs will be used to assess the efficacy of the test product before and after product application at D0 D0 Timm D14 D28 and D56 3 Questionnaire based on participant perception using Likert scale for skin soothing efficacy calming effect at D0 Timm and D28 4 To evaluate product tolerability and cutaneous acceptability by monitoring and reporting Local Intolerance LIs Adverse Events AEs and Serious Adverse Events SAEs throughout the study durationTimepoint: Visit 1 Screening D 7 to D 1 Visit 2 Baseline Visit 2 D0 and D0 Time Visit 3 Telephonic visit D14 Visit 4 Evaluation D28 plus minus 2 days End of study for non scar panel Visit 5 End of study visit D56 plus minus 2 days | — |
Countries
India
Contacts
Public ContactVidushi Bazaz
CIDP Biotech India Pvt Ltd
Outcome results
None listed