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

Phase 4

Completed

• Registration Number: CTRI/2013/06/003766
• Lead Sponsor: Apex Laboratories Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2014-02-12
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 42

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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