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To evaluate the safety of a test product in healthy volunteers.

Evaluation of Skin Safety of a test product Ciclopirox Olamine Cream USP 1 percent w/w for Primary Skin Irritation Using Skin lrritation Test (Patch Test in Humans) IS 4011 2018 Guidelines

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/01/039543
Enrollment
50
Registered
2022-01-18
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

None listed

Interventions

Intervention1: Ciclopirox Olamine Cream USP 1 % w/w: Approximately, 0.04 g of test product will be filled in wells of patch test chambers and applied on back/upper arm of participant and occluded. C

Sponsors

CIPLA LTD
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Voluntary men and women (preferably equal number of males and females) between 18 and 65 years. 2. Photo type III to V. 3. Having apparently healthy skin on test area. 4. For whom the Investigator considers that the compliance will be correct. 5. Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures. 6. Having signed a Consent Form. 7. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study. 8. Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.: exercise, sauna...), during the course of the study. 9. Should be able to read and write (in English, Hindi or local language). 10. Having valid proof of identity and age.

Exclusion criteria

Exclusion criteria: 1. Pregnancy (by history) and lactating women. Scars, excessive terminal hair or tattoo on the studied area. 2. Dermatological infection/pathology on the level of studied area. 3. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye). 4. Any clinically significant systemic or cutaneous disease, which may interfere with study procedures. 5. Chronic illness which may influence the outcome of the study. 6. Participants on any medical treatment either systemic or topical which may interfere with the performance of the study (presently or in the past 1 month). 7. Participant in an exclusion period or participating in another food, cosmetic or therapeutic trial.

Design outcomes

Primary

MeasureTime frame
Evaluation of skin irritation reactions (erythema, oedema, dryness, scaling wrinkling), using Draize scale.Timepoint: 48 hours—

Secondary

MeasureTime frame
NilTimepoint: nil—

Countries

India

Contacts

Public ContactMrs Trupti Chitre

Cipla Ltd.

trupti.chitre@cipla.com25761800

Outcome results

None listed

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