To evaluate the effect and skin safety of 2 test products [cream containing Sodium Fusidate IP equivalent to Fusidic acid 0.25% w/w in the morning and cream containing Nicotinamide IP 4% w/w in the night] on subjects with moderate pimples on face

To evaluate the efficacy and in use skin safety of 2 test products [cream containing Sodium Fusidate IP equivalent to Fusidic acid 0.25% w/w in the morning and cream containing Nicotinamide IP 4% w/w in the night] on subjects with moderate facial acne.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/06/003766

Enrollment

Registered

2013-06-19

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 RD Cream (Sodium Fusidate IP equivalent to Fusidic acid 0.25% w/w) Nicotop Cream (Nicotinamide IP 4% w/w): Sofinox RD Cream : Apply gently Â½ Finger Tip Unit â?? 1 Finger Tip U

Eligibility

Inclusion criteria

Inclusion criteria: a) Voluntary males/females with moderate inflammatory acne lesions on entire face. b) Above age of 15 years. c) No treatment for acne in the past 1 month d) All skin types (greasy, normal) except sensitive skin. e) Accepting not to use products with the same end benefit during the entire study duration. f) Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures. g) Having signed a Consent Form/Parent Consent and Child Assent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives.

Exclusion criteria

Exclusion criteria: a) Pregnant women (as confirmed by UPT) and lactating women. b) History suggestive of any hormonal problems. c) History of allergic dermatitis or contact allergy to cosmetics, d) Subjects on oral retinoid since the past 3 months. e) Hypersensitivity to any cosmetic product, raw material. f) For whom the Investigator considers that he/she will not be compliant with study procedures. g) Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures. h) 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). i) 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 â?¢ Skin Hydration Measurement of Stratum corneum using MoistureMeter SC Compact. â?¢ Measurement of Sebum content using SebumScale. â?¢ Measurement of Skin gloss using Skin GlossMeter. â?¢ Effect on skin barrier properties by VapoMeter. â?¢ Self evaluation questionnaire. â?¢ 3D image analysis of one acne lesion using PRIMOS. â?¢ Evaluatorâ??s Global Severity Scale. Timepoint: Day 0, week 1, week 2, week 4, week 8, week 12. 3D image analysis of one acne lesion using PRIMOS- Day 0, Day 3,week 1, week 2, week 4, week 8, week 12.	—

Measure

Time frame

Evaluation of inflammatory acne count â?¢ Skin Hydration Measurement of Stratum corneum using MoistureMeter SC Compact. â?¢ Measurement of Sebum content using SebumScale. â?¢ Measurement of Skin gloss using Skin GlossMeter. â?¢ Effect on skin barrier properties by VapoMeter. â?¢ Self evaluation questionnaire. â?¢ 3D image analysis of one acne lesion using PRIMOS. â?¢ Evaluatorâ??s Global Severity Scale. Timepoint: Day 0, week 1, week 2, week 4, week 8, week 12. 3D image analysis of one acne lesion using PRIMOS- Day 0, Day 3,week 1, week 2, week 4, week 8, week 12.

—

Secondary

Measure	Time frame
â?¢ Dermatological evaluation of in use skin safetyTimepoint: Week 1, Week2, Week 4,Week 8 and week 12	—

Countries

India

Contacts

Public ContactMr CN Narayanan

C.L.A.I.M.S. Pvt. Ltd.

rsjdr@rediffmail.com66758851

Outcome results