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A clinical trial to study the skin tolerance of Sodium Fusidate Cream, Framycetin Cream, and Clindamycin Phosphate Gel on people with acne prone skin.

Evaluation And Comparison Of Skin Tolerance Of 4 Test Products on acne prone skin.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/000293
Enrollment
112
Registered
2010-03-30
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: Framycetin Sulphate 1% w/w Cream: ½ Finger Tip Unit to 1 Finger Tip Unit of product on the affected area without massaging, after cleansing the area. Apply twice a day morning after b
Finger Tip Unit to 1 Finger Tip Unit of product on the affected area without massaging, after cleansing the area. Apply twice a day morning after bath and night before going to bed. Control Interventi
Finger Tip Unit to 1 Finger Tip Unit of product on the affected area without massaging, after cleansing the area. Apply twice a day morning after bath and night before going to bed.

Sponsors

Apex Laboratories Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Voluntary men/women with mild to moderate inflammatory acne lesions (greater than 5 in number) on entire face. 2.Age between 18 to 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.Dark spots and post acne scars on instrument measurement area. 3.History suggestive of any hormonal problems. 4.History of allergic dermatitis or contact allergy to cosmetics. 5.Subjects on oral retinoid since the past 3 months. 6.Hypersensitivity to any cosmetic product, raw material. 7.Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures. 8.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). 9.Subject in an exclusion period or participating in another similar cosmetic or therapeutic trial.

Design outcomes

Primary

MeasureTime frame
Dermatological evaluation of cutaneous toleranceTimepoint: Visit 2, Visit 3 and Visit 4;Dermatological evaluation of cutaneous toleranceTimepoint: Visit 2, Visit 3 and Visit 4

Secondary

MeasureTime frame
Evaluation of inflammatory acne countTimepoint: Visit 1, Visit 2, Visit 3 and Visit 4

Countries

India

Contacts

Public ContactMr C N Narayanan
rsjdr@rediffmail.com66758851

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026