None listed
Conditions
Interventions
Intervention1: Anti-stretchmark and Anti-cellulite Lotion: Mode of Usage: Apply 4 pumps of product and massage gently in circular motions over affected area.
Frequency: Twice a Day
Route of administra
Sponsors
S H Kelkar and Company Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 18 to 65 years at the time of consent. 2) Sex: Healthy males and non-pregnant females. 20 subjects with gym enthusiasts and/or others presenting with significant fresh stretchmarks and cellulite deposits on hips, thighs, knees, shoulder, arms, back and belly and 10 post-partum females with first-pregnancy-related fresh stretchmarks and cellulite. 3) Females of childbearing potential should have a self-reported negative urine pregnancy test at the time of screening visit. 4) If the female is of childbearing potential, is practising and agrees to maintain an established method of birth control (IUD, hormonal implant device/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. 5) Subject are generally in good health as determined from recent medical history. 6) Subject with significant fresh stretchmarks. 7) Subjects with cellulite deposits along with fresh stretchmarks. 8) Subjects are willing to give written informed consent and are willing to follow the study procedure. 9) Subjects who commit not to use medicated/ prescription anti-stretchmarks and anti-cellulite products or any other anti-stretchmark and anti-cellulite products other than the test product for the entire duration of the study. 10) Willing to use test product throughout the study period. 11) Subjects must be willing and able to follow the study directions and to return for all specified visits with the product. 12) Subjects are not allowed to participate in any other study until this study is complete 13) Subjects who are willing to complete all study procedures including study-related questionnaires and comply with study requirements. 14) Subjects must agree to record each use of the test product in the subject s diary card on daily basis. 15) Subjects who can read, sign, and receive a copy of Informed Consent before study.
Exclusion criteria
Exclusion criteria: 1) Subjects having active infection at site of stretchmarks. 2) Subjects who have used any topical, oral, or procedural treatment for stretchmarks and cellulite. 3) Subject is not willing to avoid unprotected sun or other UV radiation exposure during the study period. 4) Subject is currently pregnant or planning to become pregnant during the study period 5) Subject has a history of alcohol or drug addiction. 6) Subject having any other condition which could warrant exclusion from the study, as per the dermatologist s/investigator s discretion. 7) Subject with history of chronic illness which may influence the cutaneous state.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To evaluate the effectiveness of the test product in terms of change in width of the stretchmarks from baseline before and after usage of the test product. 2.To evaluate the effectiveness of the test product in terms of change in length of stretchmarks from baseline before and after usage of the test product. 3.To evaluate the effectiveness of test product in terms of change in cellulite reduction by imaging technique from baseline before and after usage of the test product. 4.To evaluate the effectiveness of test product in terms of change in skin firmness (R0) and skin elasticity (R2) from baseline before and after usage of the test product. Timepoint: 1.baseline (Day 01) before usage of test product and after usage of test product on Day 30 ( 2 days) and Day 60 ( 2 days). 2.baseline (Day 01) before usage of test product and after usage of test product on Day 30 ( 2 days) and Day 60 ( 2 days). 3.baseline (Day 01) before usage of test product and after usage of test product on Day 60 ( 2 days). 4.baseline (Day 01) before usage of test product and after usage of test product on Day 30 ( 2 days) and Day 60 ( 2 days). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the effectiveness of test product in terms of change in area of stretchmark from baseline before and after usage of the test product.Timepoint: baseline (Day 01) before usage of test product and after usage of test product on Day 30 and Day 60 .;2. To evaluate the effectiveness of test product in terms of change in appearance of stretchmarks from baseline before and after usage of the test product.Timepoint: baseline (Day 01) baseline (Day 01) before usage of test product and after usage of test product on Day 30 ( 2 days) and Day 60 ( 2 days).;3. To evaluate the effectiveness of test product in terms of change in cellulite reduction by dermal evaluation from baseline before and after usage of the test product.Timepoint: baseline (Day 01) before usage of test product and after usage of test product on Day 30 ( 2 days) and Day 60 ( 2 days).;4. To evaluate the effectiveness of test product in terms of change in subject perception questionnaire after usage of the test product.Timepoint: After usage of test product on Day 30 ( 2 days) and Day 60 ( 2 days). | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Pvt. Ltd.
Outcome results
None listed