Efficacy of Soulter Spotless Cream on reducing acne and acne scars

Not Applicable

Completed

• Conditions: Acne vulgaris. Ayurveda Condition: KSHUDRAROGAH,

• Registration Number: CTRI/2021/09/036277
• Lead Sponsor: PHARMADOCS

Brief Summary

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

**Principal investigator:** Dr. Parikshit Debnath, B.A.M.S, MD (Ay.), M.Phil (Public Health), MIPHA

**Source of monetary support:** Pharmadocs

**Protocol No.:** MPCRO/21-22/CT/001

**Primary sponsor:** Med Pharma CRO

**Study co-ordinators and study site:**

1. Mr. Subhajit Chakraborty – Madhyamgram 1

2. Ms. Monalisa Chakraborty – Madhyamgram 2

3. Ms. Nisha Srivastava – Dum Dum

4. Mr. P.K. Basu – Tollygunj

5. Mr. Partha Pratim Giri - Kasba

**Name of ethics committee:** Independent Ethics Committee (CR) India, Kolkata

**Health condition studied:** Acne vulgaris / acne scars (Ayurveda – *Yauvanapidika*)

**Study type:** Single arm trial

**Intervention:** Soulter Spotless Cream

| | | | | | | |

| --- | --- | --- | --- | --- | --- | --- |

|**Sl. No.**

**Name**

**Scientific Name**

**Qty. % w/w**

**Part used**

**Form of ingredient**

**Book Reference**

|**Active Ingredients**

|1

Manjistha

*Rubia cordifolia*

1

Stem

Oil

API – I, VOL – III

|2

Neem Oil

*Azadirachta indica*

0.5

Seed oil

Oil

API – I, VOL -II

|3

Haridra Oil

*Curcuma longa*

0.5

Rhizome

Oil

API – I, VOL – I

|4

Tea tree Oil

*Melaleuca leucadendron*

1

Oil

Oil

BH.P

|5

Nirgundi Oil

*Vitex negundo*

1

Leaves oil

Oil

API – I, VOL – III

|6

Jati (Jasmine) Oil

*Jasminum officinale*

1

Leaves oil

Oil

API – I, VOL – III

|7

Kamala

*Nelumbo nucifera*

0.5

Flower

Powder

API – I, VOL – II

|8

Gulab Oil

*Rosa centifolia*

1

Flower oil

Oil

API – I, VOL – III

|9

Kalonji

*Nigella sativa*

1

Bark

Powder

API – I, VOL - I

|10

Almond Oil

*Prunus amygdalus*

1

Oil

Oil

BH.P

|11

Kumari

*Aloe barbadensis*

10

Leaves

Powder

API – I, VOL - I

|**Base and Excipients**

|12

Glyceryl Monostearate

 Q.S.

 Powder

I.P.

|13

Cetostearyl alcohol

 Q.S.

 Powder

I.P.

|14

Cetomacrogol 1000

 Q.S.

 Powder

I.P.

|15

Propylene glycol

 Q.S.

 Liquid

I.P.

|16

Stearic acid

 Q.S.

 Powder

I.P.

|17

Carbopol934

 Q.S.

 Powder

I.P.

|18

Glycerin

 Q.S.

 Liquid

I.P.

|19

Triethanolamine

 Q.S.

 Liquid

I.P.

|**Preservative**

|20

Sodium benzoate

 Q.S.

 Powder

I.P.

**Primary outcome:** Improvement in skin status w.r.t. acne vulgaris and lightening of acne scars

- Clinical assessment

- Global Acne Grading System (GAGS)

- Investigator Global Assessment of acne (IGA)

- Cardiff Acne Disability Index (CADI)

- Dermatology Life Quality Index (DLQI)

- Safety Assessment Scale

- Postinflammatory Hyperpigmentation Severity Scale

- Photographs

**Secondary outcome:** Percentage change in lesion counts for the secondary endpoint analysis. The baseline data of the evaluating parameters will be compared with the results obtained by the end of the study (15 days). No incidence of Adverse events (AE) and Serious Adverse Events (SAE) during the study period.

**Target sample size:** 80 participants

**Phase of trial:** Post Marketing Surveillance

**Study plan:** An open label observational clinical study will be undertaken under investigator and his teams in Kolkata. Total no. of volunteers/study participants: 80 + 10 % Dropouts. Participants of both sexes aged 13 – 60 and only those volunteers providing written informed consent will be enrolled for the study (without any history or present illness of COVID 19) in specific study centre under the investigator. After receiving the written consent, all participants will be assessed by physical examination. After screening for acne vulgaris and/or acne scars, participants will be enrolled. Study materials will be provided to them free of cost for their regular use, along with specific information. Participants need to apply locally Soulter Spotless Cream regularly for 15 days, 2 times a day. Diet habit/ life style modification will also be guided (do’s and don’ts). The participants will visit their specific centre (s) at baseline and at end of the study for clinical assessment along with questionnaires. Investigator will strictly follow the SOP for the study.

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-11-12
• Last Update Posted: 2022-01-11
• Study Start: 2022-05-09

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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 do’s and don’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

• 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.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

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

Name	Time	Method
Changes in quality of life (DLQI).	Adverse Events.

Trial Locations

Locations (1)

The Ayurveda Clinic and Research Centre; 🇮🇳 Kolkata, WEST BENGAL, India

The Ayurveda Clinic and Research Centre

🇮🇳Kolkata, WEST BENGAL, India

Dr Parikshit Debnath

Principal investigator

9836675720

docdebnath84@gmail.com