CTRI/2026/02/104844 [Registered on: 26/02/2026] Trial Registered Prospectively
Last Modified On:
24/02/2026
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
A clincial study to assess the safety and efficacy of Clindamycin plus Benzoyl Peroxide Gel for the treatment of patients with pimples.
Scientific Title of Study
An Open Label, Prospective, Non-comparative, Multicentric, Phase IV Clinical Study to Evaluate the Safety, Tolerability and Efficacy of Fixed Dose Combination of Clindamycin Phosphate IP 1.2 percentage w/w plus Benzoyl Peroxide IP 3.75 percentage w/w Topical Gel in the Treatment of Patients with Acne Vulgaris.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
CT/2024/11, Version No.: 00 and Dated Feb 22, 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Rajasekhara Reddy Tamma
Designation
Managing Director
Affiliation
Clinwave Research Pvt. Ltd.
Address
LIG: B/466, H. No.: 1-16-10/466, Dr. A.S. Rao Nagar, Kapra, Medchal-Malkajgiri (Dist.).
Hyderabad TELANGANA 500062 India
Phone
7989233379
Fax
Email
dr.sekhar@clinwave.co.in
Details of Contact Person Scientific Query
Name
Dr Rajasekhara Reddy Tamma
Designation
Managing Director
Affiliation
Clinwave Research Pvt. Ltd.
Address
LIG: B/466, H. No.: 1-16-10/466, Dr. A.S. Rao Nagar, Kapra, Medchal-Malkajgiri (Dist.).
TELANGANA 500062 India
Phone
7989233379
Fax
Email
dr.sekhar@clinwave.co.in
Details of Contact Person Public Query
Name
Mr Vipen Seth
Designation
President – Drug Regulatory Affairs
Affiliation
Precise Biopharma Private Limited
Address
E-311, E-312, Eastern Business District, LBS Road, Bhandup (W), Mumbai.
Mumbai (Suburban) MAHARASHTRA 400078 India
Phone
8860833301
Fax
Email
vipen@precisegroup.co.in
Source of Monetary or Material Support
Precise Biopharma Private Limited, E-311, E-312, Eastern Business District, LBS Road, Bhandup (W), Mumbai-400078, Maharashtra, India.
Primary Sponsor
Name
Precise Biopharma Private Limited
Address
E-311, E-312, Eastern Business District, LBS Road, Bhandup (W), Mumbai-400078, Maharashtra, India.
Institutional Ethics Committee, Subharti Medical College and Hospital
Submittted/Under Review
Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College Institutional Ethics Committee 2 (RCSMGMCIEC2), Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and Chhatrapati Pramila Raje General Hospital
Submittted/Under Review
Redkar Hospital Institutional Ethics Committee (RHIEC), Redkar Hospital and Research Centre
Submittted/Under Review
SMC Heart Institute Institutional Ethics Committee, SMC Heart Institute and IVF Research Centre
Submittted/Under Review
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: L700||Acne vulgaris,
Intervention / Comparator Agent
Type
Name
Details
Intervention
FDC of Clindamycin Phosphate IP 1.2 percentage w/w plus Benzoyl Peroxide IP 3.75 percentage w/w Topical Gel
Apply a pea sized amount of topical gel to the face once daily for 12 weeks.
Comparator Agent
Not Applicable.
Not Applicable.
Inclusion Criteria
Age From
12.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Male and female patients aged between 12 to 65 years (both inclusive) with a clinical diagnosis of acne vulgaris at screening or baseline visit.
2. Patients with an Investigator’s Global Assessment (IGA) score of 2 (mild) or 3 (moderate) at screening or baseline visit.
3. Patient has facial acne vulgaris, with at least 20 to a maximum of 40 inflammatory lesions (papules and pustules) and 20 to a maximum of 100 non-inflammatory lesions (open and closed comedones).
4. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening or baseline visit.
5. Patients agree not to use any product on the face during the entire course of study except for non-medicated, investigator-approved cleanser, sunscreen, face wash and make-up. Patients should continue to use these investigator-approved products for the duration of the study and should avoid any changes in these consumer products.
6. Patient with ability to understand and provide written, signed and dated informed consent form (for patients aged between greater than or equal to 18 to smaller than or equal to 65 years) or assent form (for patients aged between greater than or equal to 12 to smaller than 18 years), which must have been obtained prior to screening.
7. Patients willing to comply with all the protocol requirements throughout the study.
ExclusionCriteria
Details
1. Patients with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
2. Patients who have acne conglobata, acne fulminans, nodulocystic acne and secondary acne (e.g., chloracne and drug induced acne).
3. Patients with excessive facial hair (e.g., heavy beards or moustaches), facial tattoos or facial disfigurement that would interfere with diagnosis or assessment of acne vulgaris.
4. Patient has greater than two (2) facial nodules.
5. Patients with uncontrolled hypertension with sitting systolic BP more than or equal to 160 mmHg and or diastolic BP more than or equal to 100 mmHg at screening.
6. Patients with clinically significant impaired hepatic function (SGOT and SGPT more than 3X the UNL) and or renal dysfunction (serum creatinine more than or equal to 2.5 mg by dL) at screening or baseline visit.
7. Patient has a history of experiencing significant burning or stinging when applying any facial treatment (e.g., make-up, soap, masks, washes, sunscreens, etc.) to their face.
8. Patients who have used estrogens or oral contraceptives within 4 weeks prior to screening visit.
9. Patients with a serious and/or chronic medical condition such as chronic or active liver disease, renal impairment, heart disease, severe respiratory disease, rheumatoid arthritis, current malignancies, immunocompromised conditions, or any other disease that, in the opinion of the investigator, would interfere with the study or place the subject at unacceptable risk.
10. Patients with a history of substance abuse or dependence that in the opinion of the Investigator is considered to interfere with the patient’s participation in the study.
11. Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent or assent.
12. Patients currently taking any of the prohibited medications(s) and inability or unwillingness to discontinue them for the entire study period.
13. Patients with suspected inability or unwillingness to comply with the study procedures.
14. Patient with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Proportion of patients reporting incidences of AE and / or SAE during the study and their assessment in respect to intensity, duration, pattern and causal relationship to the study medication.
At Visit 2 - Enrolment visit (Day 1),
Visit 3 - Follow up visit / Week 4 (Day 28±4),
Visit 4 - Follow up visit / Week 8 (Day 56±4) and
Visit 5 - End of the study visit / Week 12 (Day 84±4).
Secondary Outcome
Outcome
TimePoints
Proportion of patients achieving “success” at Week 12 (“success” defined as IGA score of “clear (score=0)” or “almost clear (score=1)” and/or at least a two-point reduction in IGA score compared to baseline).
At Visit 5 - End of the study visit / Week 12 (Day 84±4)
Mean change from baseline to week 12 in inflammatory lesion (papules and pustules) count.
At Visit 1 - Screening or Baseline visit (Day -7) and
Visit 5 - End of the study visit / Week 12 (Day 84±4).
Mean change from baseline to week 12 in non-inflammatory lesion (open and closed comedones) count.
At Visit 1 - Screening or Baseline visit (Day -7) and
Visit 5 - End of the study visit / Week 12 (Day 84±4).
Percent change from baseline to week 12 in inflammatory lesion (papules and pustules) count.
At Visit 1 - Screening or Baseline visit (Day -7) and
Visit 5 - End of the study visit / Week 12 (Day 84±4).
Percent change from baseline to week 12 in non-inflammatory lesion (open and closed comedones) count.
At Visit 1 - Screening or Baseline visit (Day -7) and
Visit 5 - End of the study visit / Week 12 (Day 84±4).
Local tolerability (application site reactions) during the study.
At Visit 2 - Enrolment visit (Day 1),
Visit 3 - Follow up visit / Week 4 (Day 28±4),
Visit 4 - Follow up visit / Week 8 (Day 56±4) and
Visit 5 - End of the study visit / Week 12 (Day 84±4).
Changes in clinical laboratory parameters from baseline to end of the study visit (week 12).
At Visit 1 - Screening or Baseline visit (Day -7) and
Visit 5 - End of the study visit / Week 12 (Day 84±4).
Target Sample Size
Total Sample Size="222" Sample Size from India="222" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 4
Date of First Enrollment (India)
23/03/2026
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This
trial is an open label, prospective, non-comparative, multicentric, phase IV
clinical study to evaluate the safety, tolerability and efficacy of fixed dose
combination of Clindamycin Phosphate IP 1.2% w/w + Benzoyl Peroxide IP 3.75%
w/w Topical Gel in the treatment of patients with acne vulgaris.
Patients
who are willing and able to participate in the study will sign and date the
Informed Consent or Assent Form on the day of screening or baseline visit
(Visit 1). During this screening period, patients who are willing to give
consent or assent will be evaluated for all the eligibility criteria. Eligible patients
(male and female) aged between 12 to 65 years (both inclusive) with a clinical
diagnosis of acne vulgaris, who have
a score of 2 (mild) or 3 (moderate) on the Investigator’s Global Assessment
(IGA) at the screening / baseline visit, has facial acne vulgaris, with at
least 20 to a maximum of 40 inflammatory lesions (papules and pustules) and 20
to a maximum of 100 non-inflammatory lesions (open and closed comedones) will
be considered for the study.
After confirming the inclusion/exclusion criteria the patient
will be enrolled and provided with study medication at enrolment visit. Patients
will be provided with patient diary at enrolment visit, which needs to be
brought along with in each subsequent visit till the last visit. Follow up visits
will be done on week 4/day 28(±4), week 8/day 56(±4) and week 12/day 84(±4) (Final
Visit) of treatment to assess safety, tolerability and efficacy.