A clinical trial to study the effects of two topical applications, Adapalene (0.1 percent) and Topical Unani Formulation in patients with Acne Vulgaris .

Phase 2/3

Not yet recruiting

Lead Sponsor: National Research Institute of Unani Medicine for Skin Disorders

Brief Summary: Overall prevalence of Acne worldwide consists of 20.5%.The Prevalence was highest among the age group 16 to 24, reaching 28.4%. Drugs used in conventional medicines are effective, but these drugs are associated with multiple side effects. Keeping all these facts in consideration, Keeoing all these facts in considerations, A topical Unani Formulation given by*Hakeem Mohammad Azam Khan* (1814-1902), for *Bu**thu**r Labaniyya*is used for this clinical trial. This Randomized, Active controlled, Parallel Group, Open Label, Clinical study has planned to evaluate the Efficacy and Safety of a Topical Unani Formulation in the management of acne vulgaris. Participants fulfilling inclusion and exclusion criteria will be receive either test or control drug as per randomization, in test group participants will be receive Topical Unani Formulation as ointment for local application once daily at affected sites as per requirement, in control drug participants will be given Adapalene 0.1% gel topically once daily at affected sites as per requirement. Laboratory investigation will be done at baseline and last follow up. Duration of the study is 4 weeks. For statistical analysis Student t test will be used to find the statistically significant difference in the parameters within the group/ inter the group. All the result analysis will be done using MS excel [2019](tel:2019).

Recruitment & Eligibility

Inclusion Criteria

1.Clinically diagnosed cases of acne vulgaris.
2.Individuals exhibiting any of the subsequent signs and symptoms of Buthur Labaniyya (Comedones, Papules, Pustules, Nodules, Itching, Erythema).
GAGS score less than 30.
Clinically stable patients.
3.Participants who are competent to follow up and who will provide assent.

Exclusion Criteria

1.Individuals who are under 15 or older than 35.
2.Patients with GAGS score more than 30.
3.Individuals who suffer from other types of acne, such as eczema, rosacea, acne necrotica, or acne fulminans.
4.Patients undergoing oral contraceptive or androgen medication, or receiving corticosteroid or anticonvulsant therapy .
5.Pregnant or Lactating Women.Significant Pulmonary/ Cardiovascular/ Hepato-Renal dysfunction and other disorders requiring long-term treatment.Known cases of immunocompromised states (HIV/ AIDS etc.) Malignancies.
6.Patient who have used isotretinoin in last six months.

Primary Outcome Measures

Name	Time	Method
Change in GAGS.	0,2 and 4 weeks

Secondary Outcome Measures

Name	Time	Method
1.Change in PGA, DLQI Score from baseline	2.Improvement in symptoms from baseline

Locations (1): OPD and IPD of Department of Moalajat, NRIUMSD.
🇮🇳
Hyderabad, TELANGANA, India
OPD and IPD of Department of Moalajat, NRIUMSD.
🇮🇳Hyderabad, TELANGANA, India
Dr Sofia Sad
Principal investigator
9899531824
sofiasad.ss@gmail.com