Efficacy of Soulter Spotless Cream on reducing acne and acne scars

An open label, observational clinical study to determine the efficacy of Soulter Spotless Cream on Acne vulgaris and Acne scars

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2021/09/036277

Enrollment

Registered

2021-09-07

Start date

Unknown

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

Health Condition 1: L700- Acne vulgaris

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Subjects suffering from Acne Vulgaris and/or having acne scars. Participants willing to give written informed consent. Participants are fit and no need any hospital administration. Agree to following instruction of doâ??s and donâ??ts in regular daily lifestyle. Subjects willing to perform all study related procedures including the use of study oil, allow the physical and other tests and willing to document symptoms and medication. Subjects/ volunteers/ study participants {and /or legally accepted representative (LAR)} willing to give written informed consent and ability to adhere to dosing and visit schedules and meet study requirements.

Exclusion criteria

Exclusion criteria: Participants unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study. Inability to carry out visits for the study. Chronic & acute disorders requiring hospital admission. Known HIV-positive, Hepatitis B or C status. Volunteers/ study participants unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.

Design outcomes

Primary

Measure	Time frame
Improvement in skin status w.r.t. acne vulgaris. Lightens acne scars. Clinical assessment- 15 days. Global Acne Grading System (GAGS)- 15 days. Investigator Global Assessment of acne (IGA)- 15 days. Cardiff Acne Disability Index (CADI)- 15 days. Dermatology Life Quality Index (DLQI)- 15 days. Safety Assessment Scale- 15 days. Postinflammatory Hyperpigmentation Severity Scale- 15 days. Timepoint: Clinical assessment- 15 days. Global Acne Grading System (GAGS)- 15 days. Investigator Global Assessment of acne (IGA)- 15 days. Cardiff Acne Disability Index (CADI)- 15 days. Dermatology Life Quality Index (DLQI)- 15 days. Safety Assessment Scale- 15 days. Postinflammatory Hyperpigmentation Severity Scale- 15 days.	—

Measure

Time frame

Improvement in skin status w.r.t. acne vulgaris. Lightens acne scars. Clinical assessment- 15 days. Global Acne Grading System (GAGS)- 15 days. Investigator Global Assessment of acne (IGA)- 15 days. Cardiff Acne Disability Index (CADI)- 15 days. Dermatology Life Quality Index (DLQI)- 15 days. Safety Assessment Scale- 15 days. Postinflammatory Hyperpigmentation Severity Scale- 15 days. Timepoint: Clinical assessment- 15 days. Global Acne Grading System (GAGS)- 15 days. Investigator Global Assessment of acne (IGA)- 15 days. Cardiff Acne Disability Index (CADI)- 15 days. Dermatology Life Quality Index (DLQI)- 15 days. Safety Assessment Scale- 15 days. Postinflammatory Hyperpigmentation Severity Scale- 15 days.

—

Secondary

Measure	Time frame
Changes in quality of life (DLQI). Adverse Events. Timepoint: Changes in quality of life - DLQI - 15 days No incidence of Adverse events (AE) and Serious Adverse Events (SAE) during the study period - 15 days	—

Countries

India

Contacts

Public ContactDr Parikshit Debnath

Gananath Sen Institute of Ayurvidya and Research

docdebnath84@gmail.com9836675720

Outcome results