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

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.