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To evaluate safety and tolerability of the spray producing film over skin in subjects with some skin disease.

A multicentric, comparative, open label study to evaluate safety and tolerability of the film forming spray (FFS) in subjects with Psoriasis and other dermatological conditions like atopic dermatitis or eczema.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049491
Enrollment
150
Registered
2023-02-06
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

Health Condition 1: L209- Atopic dermatitis, unspecified

Interventions

Intervention1: Film Forming Spray over cream application: Evenly apply and / or spread the sufficient size of standard cream over the affected area based upon the selective dermatological condition an

Sponsors

Lupin Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Male or female subject between 18 to 65 years of age (both inclusive). 2) Willing to provide written informed consent. 3) Able to attend study site, apply medications, and follow instructions. 4) Clinical diagnosis of: a) mild and moderate plaque psoriasis requiring steroid topical ointment therapy; b) other dermatological condition where steroid and occlusion will be essential 5) Above mentioned skin lesions of adequate size which are localized at elbows and knees, palms and soles, nails and folds; but not localized on the head and neck, or other mechanically strained sites.

Exclusion criteria

Exclusion criteria: 1) Hypersensitivity to steroids, liquor carbonis detergens (coal tar), alcohol, fragrance. 2) Pregnant or nursing. 3) Guttate, erythrodermic or pustular psoriasis, spontaneously improving or rapidly deteriorating plaque-type psoriasis, or severe recalcitrant psoriasis requiring additional therapy. 4) Fitzpatrick skin type >5 5) Contraindication to topical steroidal preparation. 6) Not willing to provide written informed consent. 7) Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitic drugs, antiprotozoals, or antifungals.

Design outcomes

Primary

MeasureTime frame
To investigate the number of occurrence of symptoms and severity of below mentioned clinical parameters: -Dryness -Redness -Irritation -Flakiness -Tingling sensation -Sensation of cooling (Time required for clinical parameter resolution) -Time required for drying -Time duration for film to stay on without break. -Washability of the film: Time required to wash the film -Overall satisfaction: via visual analogue scale Timepoint: Within 2-4 hours after application—

Secondary

MeasureTime frame
Feeling of stickiness (gluey) in appearance: Time required to disappearedTimepoint: Within 2-4 hours after application—

Countries

India

Contacts

Public ContactMr Munzir Soniwala

Ethicare Clinical Trial Service

milansatia@ethicare-cro.com9825585119

Outcome results

None listed

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