EVALUATION AND COMPARISON OF EFFectiveness AND SKIN SAFETY during use OF 3 ANTI-Pimple TEST PRODUCTS (SOFINOX CREAM, SOFINOX RD CREAM AND CLINDAC A GEL) ON MILD TO MODERATE Pimples.

EVALUATION AND COMPARISON OF EFFICACY AND IN USE SKIN SAFETY OF 3 ANTI-ACNE TEST PRODUCTS (SOFINOX CREAM, SOFINOX RD CREAM AND CLINDAC A GEL) ON MILD TO MODERATE ACNE.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/04/002569

Enrollment

120

Registered

2012-04-12

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Sofinox Cream - Sodium Fusidate I.P. equivalent to Fusidic Acid I.P 2%w/w : Apply Â½ Finger Tip Unit â?? 1 Finger Tip Unit of product on the affected area without massaging, after clean

Eligibility

Inclusion criteria

Inclusion criteria: 1. Voluntary men/women with inflammatory acne lesions (5 - 25) on entire face. 2. Age between 18 â?? 55 3. No treatment for acne in the past 1 month 4. Phototype III and IV. 5. All skin types (greasy, normal) except sensitive skin. 6. Accepting not to use products with the same end benefit during the entire study duration. 7. For whom the Investigator considers that the compliance will be correct. 8. Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures. 9. Having signed a Consent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives.

Exclusion criteria

Exclusion criteria: 1. Pregnant women (as confirmed by UPT) and lactating women. 2. History suggestive of any hormonal problems. 3. History of allergic dermatitis or contact allergy to cosmetics, 4. Subjects on oral retinoid since the past 3 months. 5. Hypersensitivity to any cosmetic product, raw material. 6. Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures. 7. Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month). 8. Subject in an exclusion period or participating in another similar cosmetic or therapeutic trial.

Design outcomes

Primary

Measure	Time frame
Evaluation of inflammatory acne count.Timepoint: Day 0, 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, & 12 weeks.	—

Secondary

Measure	Time frame
Dermatological evaluation of cutaneous tolerance.Timepoint: Visit 1 (Day 0), Visit 2 (1 week), Visit 3 (2 weeks), Visit 4 (4 weeks), Visit 5 (6 weeks), Visit 6 (8 weeks), Visit 7 (10 weeks), Visit 8 (12 weeks).	—

Countries

India

Contacts

Public ContactCNNarayanan

suneel.vartak@gmail.com2466268

Outcome results