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A study to assess how effective and safe is the moisturizer for patients having acne who are prescribed isotretinoin

AN OPEN LABEL, OBSERVATIONAL, PROSPECTIVE, NON-COMPARATIVE, MULTICENTRE STUDY TO EVALUATE EFFECTIVENESS AND TOLERABILITY OF MOISTURISER IN ACNE PATIENTS WHO ARE PRESCRIBED ISOTRETINOIN - Complement

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/07/020458
Enrollment
200
Registered
2019-07-31
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

Health Condition 1: L988- Other specified disorders of the skin and subcutaneous tissue

Interventions

Intervention1: Moisturizer(Excela): 28 days+_ 2 days Moisturizer(Excela) application along with anti acne treatment of Isotretinoin.

Sponsors

Cipla Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. A voluntarily given, written signed dated data sharing consent from participants and/or legally acceptable representative. 2. Participants of 18 years and above of either gender who are newly prescribed Isotretinoin or who have not used oral isotretinoin for past one month for the management of acne and moisturiser (Excela) as an adjuvant therapy as per Investigatorââ?¬•s discretion.

Exclusion criteria

Exclusion criteria: 1.Any skin allergy or serious skin condition or unsuitable to participate in the study as per routine clinical practice. 2.Pregnant and lactating women 3.Participated in any clinical trial within 1 month from screening

Design outcomes

Primary

MeasureTime frame
1.Investigator Assessment at end of week 4 2.Subject Assessment at end of week 4Timepoint: 1. Investigator Assessment at end of week 4 2. Subject Assessment at end of week 4

Secondary

MeasureTime frame
To evaluate effectiveness and tolerability of moisturiser in acne patients who are prescribed isotretinoin.Timepoint: day 1, day 28

Countries

India

Contacts

Public ContactMr Abhijit Vaidya

Cipla Ltd

Sandesh.Sawant3@Cipla.com

Outcome results

None listed

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