Health Condition 1: L700- Acne vulgaris
Conditions
Interventions
Intervention1: Test Product A: 1% Salicylic Acid foaming face wash.
: Mode of Usage: Take two actuations and gently massage product all over wet face. Avoid eyes and surrounding areas. Allow it to re
Sponsors
Cipla Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1)Age: 16 to 35 years (both inclusive) old at the time of consent. 2) Sex: Healthy adult males and non-pregnant/non-lactating females. (Preferably equal number of males and females will be enrolled in the study) 3) Females of childbearing potential have a self-reported negative urine pregnancy test at the time of the screening visit and agree to follow an accepted method of birth control for the duration of the study such as condoms, foams, jellies, diaphragm, intrauterine device etc. 4) Patients are generally in good general health as determined from recent medical history. 5) Patients with acne of mild to moderate severity as per the IGA scale. 6) Patients 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. 7) Patients is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study. 8) If the Patients is of childbearing potential, is practicing 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. 9) Patients are willing to give written informed consent and are willing to come for regular follow up. 10) Patients who have not participated in a similar investigation in the past three months. 11) Willing to use test product throughout the study period.
Exclusion criteria
Exclusion criteria: 1)History of any dermatological condition of the skin disease. 2) Subject with present condition of allergic response to any cosmetic product. 3) Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti histamines, corticosteroid therapy etc.) that might influence the outcome of the study. 4) Subject having acne of severe incidence (presence of nodules, cysts) which requires pharmaceutical product. 5) Subjects had performed any acne treatment throughout the study. 6) Subjects 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. 7) History of alcohol or drug addiction 8) Subjects using other marketed anti-acne products during the study period. 9) Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion. 10) Pregnant or breastfeeding or planning to become pregnant during the study period. 11) History of chronic illness which may influence the cutaneous state. 12) Subjects participating in other similar cosmetics, devices or therapeutic trials or skincare products within the last four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of the test products in terms of 1. change in sebum level. 2. change in acne severity by investigator global assessment scale. (IGA Scale)Timepoint: Before usage of the test products on Day 01 and after usage of test products at T20 mins on Day 01, Day 07, Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of the test products in terms of 1. change in total acne lesions. 2. change in sum of open and closed comedones. 3. change in sum of papules and pustules. 4. change in pore size, acne size, and acne count. 5. change in fluorescing acne lesions. 6. change in skin glow. 7. change in skin barrier function (Trans Epidermal Water Loss). 8. change in skin hydration. 9. To evaluate the safety and cutaneous acceptability of test products in terms of change in erythema, scaling, peeling, itching, irritation, redness, burning, dryness. 10.To assess the effectiveness of the test products in terms of subject product perception questionnaire. 11. To assess the effectiveness of the test product in terms of organoleptic assessment by subjectsTimepoint: before usage of the test products on Day 01 and after usage at T20 mins on Day 01, Day 07, Day 28. | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed