None listed
Conditions
Interventions
Intervention1: Cica face wash-acne prone sensitive skin (100ml): Dosage: Liquid form
Frequency: Twice daily applied on face affected area
Duration: 30 days
Intervention2: Cica face mist (100ml): Dos
Sponsors
Believe Cosmetics PvtLtd
Eligibility
Inclusion criteria
Inclusion criteria: i. Willing to give informed consent. ii. Healthy Indian male/female volunteer aged between 18-55 years (both inclusive) iii. Must be able to adhere to the study visit schedule and other protocol requirements. iv. Willing to complete the questionnaires for the total duration of 28 days. v. Willing to avoid usage of his/her own products containing Salicylic acid, Benzoyl peroxide, topical retinoids, clay mask, charcoal mask an chemical peel for at least one week before commencement and during this study. vi. If a moisturizer or sunscreen is needed during the study, subjects must be willing to accept only acceptable products (non-comedogenic) vii. Moderate to severe black heads (31 and above score in the GAGS) of the face at Baseline. viii. 8. Subjects with 17-100 non-inflammatory lesions (open and closed comedones) and with 25-150 inflammatory lesions (papules and pustules) and 0-15 nodules (no larger than 1 cm each) and no cystic lesions
Exclusion criteria
Exclusion criteria: i. Pregnancy or breast feeding. ii. Inability to provide voluntary consent. iii. Patients with pre existing severe systemic disease necessitating long term medication. iv. Evidence of significant uncontrolled co morbid disease which in the investigators opinion would jeopardize patient participation. v. History of cancer including solid tumors hematologic malignancies and carcinoma in situ vi. Use of any topical treatment salicylic acid benzoyl peroxide retinol antibiotics 2 weeks prior to Baseline. vii. Use of topical astringents or antimicrobial soaps for one week prior to Baseline. viii. Use of any topical retinoid systemic antibiotic or topical or systemic corticosteroids in the face 4 weeks prior to Baseline. ix. Any nodule larger than 10 mm. x. Multivitamins iron supplements and folate are acceptable but should be used consistently throughout the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢% Change in the inflammatory parameters in the individual groups on Day 0 and Day 28 â?¢% Decrease in skin irritancy and Transepidermal Water Loss (TEWL) from baseline to last visit [Time: Day 0 to Day 28]. â?¢% Increase in skin hydration from baseline to last visit [Time: Day 0 to Day 28] Timepoint: Day 0 to Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Advesrse eventsTimepoint: Day 0 to Day 28 | — |
Countries
India
Contacts
Public ContactDr Ashok Godavarthi
Radiant Research Services Pvt. Ltd
Outcome results
None listed